Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K102438
PRIMALOK FACET FIXATION SYSTEM · Osteomed LP · decided 2010-09-30 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| primaLOK FF | 800-1213 | Wenzel Spine, Inc. | MRW | 00813210022034 |
| primaLOK FF | 800-1125-00 | Wenzel Spine, Inc. | MRW | 00813210021952 |
| primaLOK FF | 800-1203 | Wenzel Spine, Inc. | MRW | 00813210022003 |
| primaLOK FF | 800-1140-00 | Wenzel Spine, Inc. | MRW | 00813210021983 |
| primaLOK FF | 800-1211 | Wenzel Spine, Inc. | MRW | 00813210022010 |
| primaLOK FF | 800-1145-00 | Wenzel Spine, Inc. | MRW | 00813210021990 |
| primaLOK FF | 800-1135-00 | Wenzel Spine, Inc. | MRW | 00813210021976 |
| primaLOK FF | 800-1130-00 | Wenzel Spine, Inc. | MRW | 00813210021969 |
| primaLOK FF | 800-1212 | Wenzel Spine, Inc. | MRW | 00813210022027 |