Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K101765
KYPHON ANCHOR FACET SCREW SYSTEM · Medtronic Spine, LLC · decided 2010-10-22 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ANCHOR FS™ Facet Fixation System | PFF0040 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00643169099425 |
| Medtronic Reusable Instruments | PFF0040 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00613994808257 |
| ANCHOR FS™ Facet Fixation System | PFF0035 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00643169099418 |
| Medtronic Reusable Instruments | PFF0035 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00613994808240 |
| Medtronic Reusable Instruments | PFF0030 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00613994808233 |
| ANCHOR FS™ Facet Fixation System | PFF0025 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00643169099395 |
| ANCHOR FS™ Facet Fixation System | PFF0030 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00643169099401 |
| Medtronic Reusable Instruments | PFF0025 | MEDTRONIC SOFAMOR DANEK, INC. | MRW | 00613994808226 |