The following data is part of a premarket notification filed by Alphatec/nexmed with the FDA for Zodiac Spinal Fixation System.
| Device ID | K051286 |
| 510k Number | K051286 |
| Device Name: | ZODIAC SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| Contact | Ellen A Yarnall |
| Correspondent | Ellen A Yarnall ALPHATEC/NEXMED 6110 CORTE DEL CEDRO Carlsbad, CA 92009 |
| 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 | 2005-05-18 |
| Decision Date | 2005-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856069022 | K051286 | 000 |
| 00844856069015 | K051286 | 000 |
| 00844856069008 | K051286 | 000 |
| 00844856068995 | K051286 | 000 |
| 00844856068988 | K051286 | 000 |
| 00844856068971 | K051286 | 000 |
| 00844856068964 | K051286 | 000 |
| 00844856057500 | K051286 | 000 |