The following data is part of a premarket notification filed by Seaspine, Inc. with the FDA for Integra Facet Fixation System.
| Device ID | K132859 |
| 510k Number | K132859 |
| Device Name: | INTEGRA FACET FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| Contact | Michelle Willis |
| Correspondent | Michelle Willis SEASPINE, INC. 2302 LA MIRADA DR. Vista, CA 92081 -7862 |
| 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 | 2013-09-12 |
| Decision Date | 2013-11-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981143183 | K132859 | 000 |
| 10889981076641 | K132859 | 000 |
| 10889981076634 | K132859 | 000 |
| 10889981076610 | K132859 | 000 |
| 10889981076597 | K132859 | 000 |
| 10889981076573 | K132859 | 000 |
| 10889981076559 | K132859 | 000 |
| 10889981076535 | K132859 | 000 |
| 10889981076511 | K132859 | 000 |
| 10889981076894 | K132859 | 000 |
| 10889981076917 | K132859 | 000 |
| 10889981076931 | K132859 | 000 |
| 10889981143176 | K132859 | 000 |
| 10889981122836 | K132859 | 000 |
| 10889981122485 | K132859 | 000 |
| 10889981077037 | K132859 | 000 |
| 10889981077020 | K132859 | 000 |
| 10889981077006 | K132859 | 000 |
| 10889981076979 | K132859 | 000 |
| 10889981076955 | K132859 | 000 |
| 10889981076467 | K132859 | 000 |