The following data is part of a premarket notification filed by Alphatec/nexmed with the FDA for Zodiac Spinal Fixation System.
| Device ID | K050830 |
| 510k Number | K050830 |
| Device Name: | ZODIAC SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| Subsequent Product Code | KWQ |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856069404 | K050830 | 000 |
| 00844856031739 | K050830 | 000 |
| 00844856031746 | K050830 | 000 |
| 00844856031753 | K050830 | 000 |
| 00844856031760 | K050830 | 000 |
| 00844856057517 | K050830 | 000 |
| 00844856069367 | K050830 | 000 |
| 00844856069374 | K050830 | 000 |
| 00844856069381 | K050830 | 000 |
| 00844856069398 | K050830 | 000 |
| 00844856031722 | K050830 | 000 |