Spinal Vertebral Body Replacement Device - Cervical
Orthopedic · 21 CFR 888.3060
Vertebral body replacement in the cervical spine.
Recent MDR events
13 adverse event reports on file
- ASCEND NANOTEC VBR SYSTEMJul 15, 2026InjuryAlphatec Spine, Inc.2027467-2026-00148
- ASCEND VBR SYSTEMFeb 26, 2026MalfunctionAlphatec Spine, Inc.2027467-2026-00029
- CORPECTOMY CAGE WITH SET SCREW; SIZE 12X14MM, 22-28MM, 0°, 0-20°Feb 5, 2026MalfunctionK2m, Inc.3004774118-2026-00032
- ASCEND VBR SYSTEMJun 6, 2025InjuryAlphatec Spine, Inc.2027467-2025-00094
- NUVASIVE X-CORE EXPANDABLE VBR SYSTEM, NUVASIVE X-CORE MINI CERVICAL EXPANDABLEJun 2, 2022MalfunctionNuvasive, Incorporated2031966-2022-00099
- UNKNOWN_K2M_PRODUCTMay 25, 2021InjuryStryker Spine-us3004774118-2021-00151
- UNKNOWN_K2M_PRODUCTMay 25, 2021InjuryK2m, Inc.3004774118-2021-00154
- UNKNOWN_K2M_PRODUCTMay 25, 2021InjuryK2m, Inc.3004774118-2021-00155
- T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEMFeb 1, 2021MalfunctionMedtronic Sofamor Danek Usa, Inc1030489-2021-00116
- T2 STRATOSPHERE EXPANDABLE CORPECTOMY SYSTEMDec 18, 2020MalfunctionMedtronic Sofamor Danek Usa, Inc1030489-2020-01814
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
109 firms currently registered for this product code
Isomedix Operations Inc.
Chester, NY, US
Shandong Weigao Orthopaedic Device Co.,ltd
weihai Shandong, CN
Choice Spine Llc
Knoxville, TN, US
Globus Medical, Inc.
Memphis, TN, US
Mackay Manufacturing, Inc.
Spokane Valley, WA, US
Nuvasive, Inc.
SAN DIEGO, CA, US
Arch Medical Solutions - Memphis
BARTLETT, TN, US
Globus Medical, Inc.
AUDUBON, PA, US
3d Systems - Layerwise
Heverlee Vlaams Brabant, BE
Quality Tech Services, Llc
Bloomington, MN, US
Stryker Spine
ALLENDALE, NJ, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Alphatec Spine, Inc.
Carlsbad, CA, US
First Article Inc
Souderton, PA, US
Zavation
Flowood, MS, US
Omnia Medical
MORGANTOWN, WV, US
Infigo Medical
Miami, FL, US
Sterigenics Us, Llc
Lewis Center, OH, US
Turner Medical Inc.
Athens, AL, US
Donson Machine Company
ALSIP, IL, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Sterigenics Us Llc
Fort Worth, TX, US
510(k) clearances
19 clearances for this product code
- Atlas Spine, Inc.Jul 15, 2026
K252822 · Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant
- Atlas Spine, Inc.Nov 10, 2025
K252560 · Atlas Spine HiRISE Expandable Cervical Corpectomy System
- MiRus, LLCOct 13, 2023
K232481 · RIGEL 3DR Anterior Cervical Corpectomy System
- Bright SpineJan 13, 2023
K221542 · Galileo Vertebral Body Replacement Device
- Cmf Medicon Surgical, Inc.Apr 4, 2022
K212126 · MediExpand Cervical Expandable VBR System
- K2m, Inc.Feb 24, 2022
K211320 · CAPRI Corpectomy Cage System
- Bright SpineApr 21, 2020
K192145 · Galileo Vertebral Body Replacement Device
- Nexxt Spine, LLCFeb 24, 2020
K193412 · NEXXT MATRIXX System