The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Bridgepoint Spinous Process Camp- Posterior Fixation System.
| Device ID | K103205 |
| 510k Number | K103205 |
| Device Name: | BRIDGEPOINT SPINOUS PROCESS CAMP- POSTERIOR FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
| Contact | Olga Lewis |
| Correspondent | Olga Lewis ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2011-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856059191 | K103205 | 000 |
| 00844856059184 | K103205 | 000 |
| 00844856059177 | K103205 | 000 |