The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac Adjustable Bridges, Models 11-20xx,11-25xx,11-30xx,11-35xx.
| Device ID | K061321 |
| 510k Number | K061321 |
| Device Name: | ZODIAC ADJUSTABLE BRIDGES, MODELS 11-20XX,11-25XX,11-30XX,11-35XX |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
| Contact | Paula Morgan |
| Correspondent | Paula Morgan ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-11 |
| Decision Date | 2006-07-07 |
| Summary: | summary |