Fastener, Plate, Cranioplasty
Neurology · 21 CFR 882.5360
Recent MDR events
81 adverse event reports on file
- SCR,UNIII AXS, SD,1.5X5MMJul 30, 2026InjuryStryker Leibinger Freiburg0008010177-2026-00124
- 1.5X6MM HT SD X-DR SCR 5-PKMay 28, 2026MalfunctionBiomet Microfixation0001032347-2026-00128
- 1.5X6MM HT SD X-DR SCR 5-PKMay 28, 2026MalfunctionBiomet Microfixation0001032347-2026-00129
- MOTOR MR8 ELECTRIC NAVIGATED S8Oct 30, 2025MalfunctionMdt Powered Surgical Solutions1625507-2025-02245
- 1.5X4MM HT SD X-DR SCR EAMay 29, 2025InjuryBiomet Microfixation0001032347-2025-00220
- 1.5X4MM HT SD X-DR SCR EAMay 29, 2025InjuryBiomet Microfixation0001032347-2025-00221
- 1.5X4MM HT SD X-DR SCREWOct 23, 2024MalfunctionBiomet Microfixation0001032347-2024-00331
- 2.0X5MM HT X-DRIVE SCREWAug 27, 2024InjuryBiomet Microfixation0001032347-2024-00286
- PLT/QUIKFLAP 3X2 SD AXSJun 17, 2024InjuryStryker Leibinger Freiburg0008010177-2024-00050
- RESORB XGOct 13, 2023InjuryKls Martin Se & Co. Kg9610905-2023-00052
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
59 firms currently registered for this product code
Depuy Synthes Sales
Bridgewater, MA, US
Jeil Medical Corporation
Seoul, KR
Viant As&o Holdings, Llc
LACONIA, NH, US
Stryker Leibinger Gmbh & Co. Kg
FREIBURG Baden-Wurttemberg, DE
Synthes Gmbh / Synthes Produktions Gmbh
Oberdorf, Baselland Basel-Landschaft, CH
Depuy Cmw
BLACKPOOL, LANCASHIRE, GB
Steris Schweiz Ag
Daniken Solothurn, CH
Kls-martin L.p.
Jacksonville, FL, US
Aesculap, Inc.
CENTER VALLEY, PA, US
Sterigenics U.s. Llc
MULBERRY, FL, US
Osteonic Co., Ltd.
Seoul, KR
Inion Oy
TAMPERE Pirkanmaa, FI
Kinamed, Inc.
CAMARILLO, CA, US
Sterigenics Radiation Technologies, Llc
San Diego, CA, US
Synthes (usa) Products Llc
West Chester, PA, US
The E F Precision Group
WILLOW GROVE, PA, US
Microware Precision Co., Ltd.
Taichung, TW
Depuy Orthopaedics
BRIDGEWATER, MA, US
Quanzhou Apex Hygiene Products Co.,ltd
Jinjiang Fujian, CN
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
510(k) clearances
7 clearances for this product code
- Inion OYJul 11, 2025
K251472 · Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation System
- Stryker Leibinger GmbH & Co KGAug 14, 2023
K231208 · Stryker Resorbable Fixation System
- StrykerMay 19, 2017
K171152 · Stryker Universal Neuro III System AXS Screw
- StrykerJun 24, 2015
K151387 · Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade
- Depuy Synthes Companies of Johnson & JohnsonMar 27, 2015
K141385 · DEPUY SYNTHES INJECTABLE POLYMER SYSTEM (IPS)
- Porex Surgical, Inc.Dec 3, 2010
K101835 · MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079
- Biomedical Ent., Inc.Mar 13, 2001
K001353 · MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEM