The following data is part of a premarket notification filed by Medtronic Spine Llc. with the FDA for Kyphon Anchor Facet Screw System.
| Device ID | K101765 |
| 510k Number | K101765 |
| Device Name: | KYPHON ANCHOR FACET SCREW SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | MEDTRONIC SPINE LLC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Contact | Erica Hoffman |
| Correspondent | Erica Hoffman MEDTRONIC SPINE LLC. 1221 CROSSMAN AVE. Sunnyvale, CA 94089 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-23 |
| Decision Date | 2010-10-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994808257 | K101765 | 000 |
| 00613994808240 | K101765 | 000 |
| 00613994808233 | K101765 | 000 |
| 00613994808226 | K101765 | 000 |
| 00643169099425 | K101765 | 000 |
| 00643169099418 | K101765 | 000 |
| 00643169099401 | K101765 | 000 |
| 00643169099395 | K101765 | 000 |