510(k) clearances for Thoracolumbosacral Pedicle Screw System

905 on file · showing the 200 most recent

Zavation Medical Products, LLCJul 24, 2026
K253943 · Tiger 2 System
MANTIZ Co., Ltd.Jul 24, 2026
K260362 · QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
Alphatec Spine, Inc.Jul 14, 2026
K261284 · Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation System
S.M.A.I.OJul 1, 2026
K253802 · KHEIRON® Spinal Fixation System, including patient specific K-ROD
Socko Medical Co., Ltd.Jun 17, 2026
K253045 · Socko Vimax Spinal Fixation System
Chanpin Medtak Co., Ltd.Jun 9, 2026
K251251 · ChanPin Pedicle Screw Spinal System
Kyocera Medical Technologies Inc. (KMTI)May 15, 2026
K260989 · Varion Thoracolumbar Fixation System
Globus Medical, Inc.May 7, 2026
K253739 · SCRIPT Rods, CREO Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline System
L&K BIOMED Co., Ltd.May 5, 2026
K261130 · AccelFix Spinal Fixation System
Spineart SAMay 1, 2026
K253966 · PERLA® TL Posterior Thoraco-lumbar Fixation System
ZheJiang Decans Medical Devices Co., Ltd.Apr 29, 2026
K252542 · LEO Spinal System
Medacta International S.A.Apr 28, 2026
K253940 · M.U.S.T. Pedicle Screw System - Extension
Medtronic Sofamor Danek USA, Inc.Apr 21, 2026
K260216 · CD Horizon ModuLeX Fenestrated Screw Set; CD Horizon ModuLeX Spinal System
Life Spine, Inc.Apr 16, 2026
K254274 · ARx® SAI Implant System
S.M.A.I.OApr 3, 2026
K260786 · KHEIRON® Spinal Fixation System, including patient specific K-ROD
Osteomni, Inc.Feb 24, 2026
K254247 · OSTEOMNI SPINAL FIXATION SYSTEM
Box Spine, LLCFeb 23, 2026
K253169 · Duet Spinal Fixation System
K2m, Inc.Feb 10, 2026
K253545 · Vulcan Spinal System
Spinal Resources, Inc.Jan 13, 2026
K252461 · Swedge Pedicle Screw Fixation System Bezier Rod
Medtronic Sofamor Danek USA, Inc.Jan 7, 2026
K253941 · CD Horizon ModuLeX Spinal System (LigaMAS Head Assembly)
S.M.A.I.OJan 7, 2026
K253990 · KHEIRON® Spinal Fixation System, including patient specific K-ROD
Highridge Medical, LLCDec 17, 2025
K253093 · Vital Spinal Fixation System
S.M.A.I.ODec 17, 2025
K253721 · KHEIRON® Spinal Fixation System, including patient specific K-ROD
Double Medical Technology, Inc.Nov 18, 2025
K252729 · Universal Spinal System
Beijing Fule Science & Technology Development Co., Ltd.Oct 24, 2025
K252730 · Fule Spinal Fixation System
Medtronic Sofamor Danek USA, Inc.Oct 24, 2025
K253335 · CD Horizon Spinal System
Medos International SARLOct 21, 2025
K253249 · TriALTIS Spine System
Astura MedicalOct 21, 2025
K252346 · OLYMPIC Posterior Spinal Fixation System; MASADA Modular Spinal Fixation System
Allumin8, Inc.Oct 20, 2025
K242827 · A8 INTEGR8 Porous Pedicle Screws
Nexus SpineOct 14, 2025
K253331 · PressON Spinal Fixation System
ImplanetAug 28, 2025
K252437 · JAZZ Spinal System
S.M.A.I.OJul 8, 2025
K251804 · KHEIRON® Spinal Fixation System, including patient specific K-ROD
Ulrich Medical USA, Inc.Jul 1, 2025
K251719 · Momentum® Posterior Spinal Fixation System
SeaSpine Orthopedics CorporationJun 18, 2025
K250908 · Virata Spinal Fixation System
Ht Medical D.B.A. Xenix MedicalJun 12, 2025
K251154 · RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments
Spine Wave, Inc.Jun 6, 2025
K251131 · Annex® 2 Adjacent Level System
CG Bio Co., Ltd.May 8, 2025
K250582 · COLONNADE Posterior Screw Fixation System
Eminent SpineApr 28, 2025
K241663 · Eminent Spine 3D Titanium Pedicle Screw System
HC Biologics, LLCMar 27, 2025
K250092 · HC Biologics Osteopoint Spinal Fixation System
Icotec AGFeb 27, 2025
K242900 · VADER® Pedicle System and VADER®one Pedicle System
Spinal Elements, Inc.Feb 21, 2025
K243916 · Primus Spinal Fixation System
Zavation Medical Products, LLCFeb 3, 2025
K243908 · Tiger 2 System
Medos International SARLJan 17, 2025
K243249 · TriALTIS Spine System
Effortmed, LLCJan 15, 2025
K243946 · EffortMed Spinal Fixation System
Astura MedicalJan 7, 2025
K243259 · MASADA Modular Spinal Fixation System
Neo Medical SADec 23, 2024
K243693 · NEO Pedicle Screw System
Precision Spine, Inc.Dec 17, 2024
K242297 · Reform Pedicle Screw System
Lock-In USA CorpDec 13, 2024
K243281 · LOCK-IN Spinal Fixation System
Solco Biomedical Co., Ltd.Nov 26, 2024
K231655 · 4CIS® Chiron Spinal Fixation System
Cmf Medicon Surgical, Inc.Nov 13, 2024
K242764 · MediRod Pedicle Screw System
Jeil Medical CorporationNov 8, 2024
K243004 · Xpine Spinal Fixation System
CarboFix Orthopedics , Ltd.Nov 5, 2024
K243106 · CarboClear® Hybrid Pedicle Screw System
Spinal Alignment Solutions, Inc.Oct 28, 2024
K242350 · Spinal Alignment Solutions Pelvic Incidence (PI) Rod System
Medtronic Sofamor Danek USA, Inc.Oct 23, 2024
K243007 · CD Horizon Spinal System
Baui Biotech Co., Ltd.Oct 17, 2024
K242899 · NOVA Minimally Invasive System
Greens Surgicals Pvt. , Ltd.Oct 10, 2024
K230325 · GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System
Mikron Makina Sanayi VE Ticaret Ltd. Sti.Sep 30, 2024
K241657 · MSFX MIKRON SPINAL FIXATION SYSTEM
S.H.Pitkar Orthotools Pvt. , Ltd.Sep 9, 2024
K240233 · Pitkar Spinal Pedicle Screw System
Medos International SARLSep 9, 2024
K242042 · TriALTIS Spine System
Eminent SpineSep 3, 2024
K242069 · Eminent Spine Scoliosis Deformity Pedicle Screw System
Orthopeasia Co., Ltd.Aug 30, 2024
K240180 · Orthopeasia Spinal Fixation System
Xtant Medical Holdings, Inc.Aug 2, 2024
K241892 · Cortera Spinal Fixation System
CarboFix Orthopedics , Ltd.Aug 1, 2024
K233793 · CarboClear® X Pedicle Screw System
Pantheon SpinalJul 26, 2024
K241494 · Pantheon Pedicle Screw and Iliac Bolt Fixation System
ClarianceJul 24, 2024
K241863 · Erisma® Lp Spinal Fixation System; Erisma® LP MIS
Alphatec Spine, Inc.Jun 21, 2024
K241519 · Invictus® Small Stature Spinal Fixation System
Teslake, Inc.Jun 6, 2024
K240963 · Spinal System
Ingenium SpineJun 4, 2024
K241258 · Ingenix Spinal System
Innovasis, Inc.May 20, 2024
K241276 · Vector Pedicle Screw System
ImplanetMay 6, 2024
K240392 · JAZZ Spinal System
Spine Wave, Inc.May 6, 2024
K240685 · Salvo® Spine System
Stryker InstrumentsApr 29, 2024
K240526 · POWEReam Xia/Serrato
ClarianceApr 26, 2024
K240872 · Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System
CarboFix Orthopedics , Ltd.Apr 25, 2024
K240846 · CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement
SeaSpine Orthopedics CorporationApr 19, 2024
K232566 · NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
G Surgical, LLCApr 5, 2024
K240737 · G Surgical Marksman MIS System
GS Medical Co., Ltd.Apr 3, 2024
K240350 · AnyPlus II Spinal Fixation System
Medtronic Sofamor Danek USA, Inc.Mar 27, 2024
K233951 · CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw)
Zimvie Spine (Zimmer Biomet Spine, Inc.)Mar 15, 2024
K240539 · Vital Spinal Fixation System
Solco Biomedical Copany India Private LimitedFeb 27, 2024
K232607 · 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM
Icotec AGFeb 26, 2024
K232628 · VADER® Pedicle System
Medacta International S.A.Feb 13, 2024
K234048 · M.U.S.T. Pedicle Screw System - Extension
Innosys Co., Ltd.Feb 6, 2024
K233960 · INNOVERSE Spinal System
CarboFix Orthopedics , Ltd.Jan 10, 2024
K233944 · CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments
Stryker InstrumentsDec 26, 2023
K233300 · POWEReam 1/4 Drive
Medos International SARLDec 12, 2023
K233684 · TriALTIS Spine System
Life Spine, Inc.Dec 12, 2023
K233455 · ARx MIS Spinal Screw System
Osteomed Indústria E Comércio DE Implantes LtdaNov 21, 2023
K231443 · Mini-OSTEO Pedicle Fixation System
Premia Spine, Ltd.Nov 21, 2023
K232719 · ProMIS Extension Rod System
Astura MedicalNov 16, 2023
K231694 · MASADA Modular Spinal Fixation System
Nexus Spine, LLCOct 26, 2023
K233234 · PressON Spinal Fixation System
Innosys Co., Ltd.Oct 26, 2023
K231737 · ANAX 5.5 Spinal System
Spineart SAOct 25, 2023
K231069 · PERLA® TL Posterior Thoraco-lumbar Fixation System
K&J Consulting Corp.Oct 24, 2023
K232586 · Rexious Spinal Fixation System, Statera Spinal System, Statera-M Spinal System
Sagico VA USA, LLCOct 23, 2023
K232561 · Ripley Spinal Screw System by SAGICO
Vy Spine, LLCOct 13, 2023
K231744 · VyLink Spinal Screw System
Zimvie Spine (Zimmer Biomet Spine, Inc.)Oct 11, 2023
K230116 · Vital Spinal Fixation System
Shanghai Sanyou Medical Co, Ltd.Oct 10, 2023
K230961 · Zeus Spinal System
SpinewayOct 10, 2023
K231658 · VEOS Spinal Fixation System
CarboFix Orthopedics , Ltd.Oct 10, 2023
K232341 · CarboClear® Pedicle Screw System
S.M.A.I.OSep 29, 2023
K232650 · KHEIRON® Spinal Fixation System, including patient specific K-ROD
Alphatec Spine, Inc.Sep 27, 2023
K232275 · Invictus® Spinal Fixation System
Medos International SARLSep 22, 2023
K231479 · TriALTIS Spine System
Kalitec MedicalSep 15, 2023
K230974 · NIDO Pedicle Screw System
Medyssey USA, Inc.Aug 24, 2023
K232218 · Zenius Spinal System
Zavation Medical Products, LLCAug 22, 2023
K231811 · Zavation Connector System
Medtronic Sofamor Danek USA, Inc.Aug 16, 2023
K232141 · CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head)
L&K BIOMED Co., Ltd.Aug 14, 2023
K232311 · LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System
Integrity Implants, Inc.Aug 7, 2023
K231098 · LineSider® Spinal System
Shanghai Sanyou Medical Co, Ltd.Jul 28, 2023
K231931 · Adena-Zina Spinal System
Nexxt Spine, LLCJul 20, 2023
K231799 · INERTIA® CONNEXX Modular Pedicle Screw System
Premia Spine, Ltd.Jul 7, 2023
K231844 · ProMIS Fixation System
Silony Medical GmbHJul 6, 2023
K223806 · VERTICALE® Triangular Fixation System
CarboFix Orthopedics , Ltd.Jul 3, 2023
K231280 · CarboClear® X Pedicle Screw System; CarboClear® X Navigated Instruments; CarboClear® X Fenestrated Pedicle Screw System with High V+® Bone Cement
L&K BIOMED Co., Ltd.Jun 27, 2023
K231636 · LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
Jmt Co., Ltd.Jun 15, 2023
K230762 · EDEN Spinal Fixation MIS System
Stryker SpineJun 8, 2023
K222684 · XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2 Spinal System, ES2 Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi
Republic Spine, LLCMay 26, 2023
K223096 · Dark Star Deformity Pedicle Screw System
CG Bio Co., Ltd.May 25, 2023
K222229 · Advanced LumFix Spinal Fixation System
Nexus Spine, LLCMay 2, 2023
K223529 · PressON Spinal Fixation System
Artfx Medical, LLCApr 20, 2023
K212220 · ArtFX Spinal Fixation System
Altus SpineApr 19, 2023
K230766 · Altus Spine Monaco Pedicle Screw System
Spinal Resources, Inc.Mar 23, 2023
K230482 · Swedge Pedicle Screw Fixation System
OrthoPediatrics Corp.Mar 23, 2023
K222105 · RESPONSE 5.5/6.0 Cannulated Screw System
L&K BIOMED Co., Ltd.Feb 28, 2023
K230245 · LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System; AccelFix Spinal Fixation System
G Surgical, LLCFeb 9, 2023
K230063 · G Surgical Marksman Spinal Deformity System
MedtronicJan 23, 2023
K223494 · CD Horizon Spinal System
Nu Vasive, IncorporatedJan 11, 2023
K223181 · NuVasive Reline System
L&K BIOMED Co., Ltd.Dec 23, 2022
K223565 · LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System.
Spinecraft, LLCDec 22, 2022
K223273 · ASTRA Spine System
Zavation Medical Products, LLCDec 5, 2022
K222614 · Zavation Spinal System
Spinal Elements, Inc.Dec 1, 2022
K222516 · Mercury® II Spinal System
Ulrich Medical USANov 28, 2022
K223274 · Momentum® MIS Posterior Spinal Fixation System
Taeyeon Medical Co., Ltd.Nov 15, 2022
K212700 · Dyflex-II
Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.Oct 28, 2022
K222031 · Spinal Inner Fixation System
Dio Medical CorporationOct 25, 2022
K222415 · Rexious Spinal Fixation System
Medos-International SarlOct 13, 2022
K222473 · EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE Ultra Rods
Medtronic Sofamor Danek USA, Inc.Oct 4, 2022
K221646 · CD HORIZON ASTUTE SPINAL SYSTEM; CD HORIZON Growth Rod Conversion Set; CD HORIZON SPINAL SYSTEM; CD Horizon Fenestrated Screw Set; COLORADO 2 SPINAL System; GDLH POSTERIOR SPINAL SYSTEM; SHILLA Growth Guidance System; TENOR SPINAL SYSTEM
Altus Partners, LLCSep 16, 2022
K211027 · Altus Spine Pedicle Screw System
Innovative Surgical Designs, Inc.Sep 16, 2022
K220297 · True Tulip, True M.I.S.
SeaSpine Orthopedics CorporationSep 7, 2022
K222110 · Mariner RDX System
Shanghai Reach Medical Instrument Co, Ltd.Aug 31, 2022
K221745 · Sterile Posterior Spinal Fixation System
Spine Wave, Inc.Aug 29, 2022
K222362 · Salvo® Spine System
Surgalign Spine TechnologiesAug 19, 2022
K221403 · Cortera Spinal Fixation System
Corelink, LLCAug 9, 2022
K221776 · NextGen Pedicle Screw System
Nexxt Spine, LLCJul 28, 2022
K221905 · INERTIA CONNEXX Modular Pedicle Screw System
OsteoCentric TechnologiesJul 28, 2022
K221332 · OsteoCentric Spine MIS Pedicle Fastener System
Rivarp Medical Private LimitedJul 22, 2022
K220486 · Kentrospine PSS Pedicle Screw System
Jmt Co., Ltd.Jun 23, 2022
K201788 · EDEN Spinal Fixation System
S.M.A.I.OJun 9, 2022
K211981 · KHEIRON® Spinal Fixation System
Solco Biomedical Co., Ltd.Jun 1, 2022
K203233 · 4CIS Chiron Spinal Fixation System
MedtronicMay 25, 2022
K221244 · CD Horizon Spinal System
Tdm Co., Ltd.May 19, 2022
K220285 · PINE Pedicle Screw System
Life Spine, Inc.May 2, 2022
K220341 · ARx Modular Spinal System
Medicrea InternationalApr 8, 2022
K220724 · CD Horizon Spinal System and PASS LP Spinal System
Alphatec Spine, Inc.Apr 4, 2022
K214006 · Invictus® Spinal Fixation System
Life Spine, Inc.Mar 31, 2022
K220025 · ARx® Spinal System
Medos International SARLMar 8, 2022
K220374 · EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws)
Vy Spine, LLCFeb 28, 2022
K213750 · VyLink Spinal Screw System
Innovative Surgical Designs, Inc.Feb 18, 2022
K212627 · True Tulip, True M.I.S.
SpineartJan 21, 2022
K213470 · PERLA® TL Posterior Osteosynthesis System
Medicrea International SAJan 5, 2022
K213281 · PASS LP Spinal System, CD Horizon Spinal System
Alphatec Spine, Inc.Dec 10, 2021
K213460 · Invictus Spinal Fixation System
SeaSpine Orthopedics CorporationSep 21, 2021
K212692 · Mariner Pedicle Screw System
Biedermann Motech GmbH & Co. KGAug 20, 2021
K203607 · MOSS VRS Spinal System
Intelivation, LLCAug 19, 2021
K212185 · Golden Isles Pedicle Screw System
Shanghai Sanyou Medical Co, Ltd.Aug 16, 2021
K212066 · Adena-Zina System
S.M.A.I.OAug 10, 2021
K211414 · KHEIRON Spinal Fixation System
Medtronic Sofamor Danek USA, Inc.Jul 21, 2021
K211958 · CD Horizon Spinal System
Aesculap Implant Systems, LLCJul 19, 2021
K210963 · ENNOVATE Spinal System
Ortho Development CorporationJul 14, 2021
K203023 · Pisces Spinal System
Zavation Medical Products, LLCJul 12, 2021
K211113 · Zavation Spinal System
SeaSpine Orthopedics CorporationJun 23, 2021
K211606 · Mariner Deformity System
Shanghai Reach Medical Instrument Co, Ltd.Jun 21, 2021
K201737 · Posterior Spinal Fixation System
Spinecraft, LLCJun 3, 2021
K211323 · ASTRA Spine System
Coligne AGMay 19, 2021
K210306 · GII Spinal Fixation System
Innovative Surgical Designs, Inc.May 18, 2021
K210816 · True Tulip, True M.I.S.
Reliance Medical Systems, LLCMay 13, 2021
K210874 · Reliance Spinal Screw System
MedtronicApr 30, 2021
K210637 · CD Horizon Spinal System
Life Spine, Inc.Apr 22, 2021
K210549 · ARx Spinal System
Medacta International S.A.Apr 20, 2021
K210427 · M.U.S.T. Midline Cortical (MC) Screw System
Medynus, Inc.Apr 19, 2021
K210420 · Goblin and Goblin LS Pedicle Screw Systems
Corelink, LLCApr 15, 2021
K210539 · CoreLink Midline Fixation System
Auxein Medical Private Limited/71164Apr 6, 2021
K201457 · Auxein Brand Vertaux 5.5 mm Pedicle Screw System
CarboFix Orthopedics , Ltd.Apr 6, 2021
K210716 · CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments
Zimmer Biomet Spine, Inc.Apr 2, 2021
K210275 · Polaris Spinal System
Republic Spine, LLCMar 5, 2021
K201420 · Republic Spine Dark Star Spinal System
Solco Biomedical Company India Private LimitedFeb 18, 2021
K202498 · 4CIS SARA Spine System, 4CIS VERTU Spine System
Zimmer Biomet Spine, Inc.Jan 28, 2021
K203507 · Vitality® Spinal Fixation System
Altus Partners, LLCJan 26, 2021
K200922 · Altus Spine HA Pedicle Screw System
Medacta International S.A.Jan 26, 2021
K203482 · M.U.S.T. Pedicle Screw Extension and Long Tab Implants
Globus Medical, Inc.Jan 19, 2021
K203153 · CREO Stabilization System, Navigation Instruments, ExcelsiusGPS
SpineartJan 15, 2021
K203506 · PERLA® TL posterior osteosynthesis system
Getset Surgical, SAJan 11, 2021
K202505 · GetSet Surgical GoPLF! Posterior Lateral Fusion System
Nanovis, LLCDec 22, 2020
K203452 · Nano FortiFix® System
Life Spine, Inc.Dec 17, 2020
K203163 · ARx Illiac Spinal Screw System
SpineartDec 17, 2020
K203222 · PERLA TL Posterior Osteosynthesis System
L&K BIOMED Co., Ltd.Dec 4, 2020
K200789 · LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System
Integrity Implants, Inc.Dec 3, 2020
K203367 · LineSider Spinal System
CarboFix Orthopedics , Ltd.Nov 25, 2020
K203317 · CarboClear X Pedicle Screw System