The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac Polyaxial Spinal Fixation System.
| Device ID | K091189 |
| 510k Number | K091189 |
| Device Name: | ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Contact | Paula Morgan |
| Correspondent | Paula Morgan ALPHATEC SPINE, INC. 5818 EL CAMINO REAL Carlsbad, CA 92008 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-23 |
| Decision Date | 2009-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856049475 | K091189 | 000 |
| 00844856047570 | K091189 | 000 |