Implant, Fixation Device, Spinal
Orthopedic · 21 CFR 888.3060
Recent MDR events
909 adverse event reports on file
- COLLECT.NO.QAS SPINE CERVICAL STABILIS.Oct 25, 2024InjuryAesculap Ag9610612-2024-00281
- IMPLANT, FIXATION DEVICE, SPINALAug 12, 2023InjuryUnknownMW5137049
- IMPLANT, FIXATION DEVICE, SPINALAug 12, 2023InjuryUnknownMW5139985
- IMPLANT, FIXATION DEVICE, SPINALMar 24, 2023MalfunctionCtl Medical Corporation3009051471-2023-00006
- RAPAHELMar 14, 2023MalfunctionCtl Medical Corporation3009051471-2023-00005
- RAPHAELMar 8, 2023MalfunctionCtl Medical Corporation3009051471-2023-00004
- RAPHAELFeb 28, 2023MalfunctionCtl Medical Corporation3009051471-2023-00003
- RAPHAELFeb 16, 2023MalfunctionCtl Medical Corporation3009051471-2023-00002
- PICASSO IIJan 12, 2023MalfunctionCtl Medical Corporation3009051471-2022-00014
- TAURUSDec 14, 2022MalfunctionCtl Medical Corporation3009051471-2019-00024
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
19 firms currently registered for this product code
Synthes Gmbh
Selzach Solothurn, CH
Synthes (usa) Products Llc
West Chester, PA, US
Depuy Spine, Inc.
RAYNHAM, MA, US
Medtronic Engineering And Innovation Center (meic)
Hyderabad Telangana, IN
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Synthes Gmbh
Zuchwil Solothurn, CH
Warsaw Orthopedic, Inc.
WARSAW, IN, US
Lincotek Medical Llc
Vandalia, OH, US
Jabil Inc. (monument)
Monument, CO, US
Symmetry Medical Manufacturing Inc.
WARSAW, IN, US
Medos International Sarl
Le Locle Neuchatel, CH
Jabil Inc. (brandywine)
W Chester, PA, US
Eptam West Llc
Colorado Springs, CO, US
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Norwood Medical Llc
Dayton, OH, US
Sterigenics U.s., Llc
Corona, CA, US
510(k) clearances
6 clearances for this product code
- Synthes (Usa)Mar 8, 1996
K954856 · CANNULATED FEMORAL NAIL
- StuartJun 21, 1990
K897141 · SLOT STAPLES AND ADAPTOR FOR ZIELKE SPINAL FIXATIO
- Biedermann Motech GmbHApr 25, 1990
K894184 · BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM
- Roseburg SADec 7, 1987
K872715 · UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY
- Sofamor Co.Dec 7, 1987
K873977 · NEW C-D SYSTEM FOR SPINAL SURGERY
- Depuy, Inc.Oct 5, 1976
K760649 · TOTAL SPINAL CORRECTION