The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Raptor Facet Fixation System.
| Device ID | K110170 |
| 510k Number | K110170 |
| Device Name: | RAPTOR FACET FIXATION SYSTEM |
| Classification | System, Facet Screw Spinal Device |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| 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 | 2011-01-20 |
| Decision Date | 2011-11-28 |
| Summary: | summary |