The following data is part of a premarket notification filed by Depuy Spine, Inc. with the FDA for Viper F2 Facet Fixation System.
| Device ID | K101762 |
| 510k Number | K101762 |
| Device Name: | VIPER F2 FACET FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Contact | Frank Jurczak |
| Correspondent | Frank Jurczak DEPUY SPINE, INC. 325 PARAMOUNT DR. Raynham, MA 02767 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-22 |
| Decision Date | 2010-11-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705034034768 | K101762 | 000 |
| 10705034034751 | K101762 | 000 |