The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac 4.0 Polyaxial Spinal Fixation System.
| Device ID | K071890 |
| 510k Number | K071890 |
| Device Name: | ZODIAC 4.0 POLYAXIAL SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | ALPHATEC SPINE, INC. 2051 PALOMAR AIRPORT ROAD SUITE 100 Carlsbad, CA 92011 |
| Contact | Mary Stanners |
| Correspondent | Mary Stanners 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-09 |
| Decision Date | 2007-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844856024410 | K071890 | 000 |
| 00844856003880 | K071890 | 000 |
| 00844856003873 | K071890 | 000 |
| 00844856003866 | K071890 | 000 |
| 00844856003859 | K071890 | 000 |
| 00844856003842 | K071890 | 000 |
| 00844856003835 | K071890 | 000 |
| 00844856003828 | K071890 | 000 |
| 00844856002814 | K071890 | 000 |
| 00844856002807 | K071890 | 000 |
| 00844856002791 | K071890 | 000 |
| 00844856002784 | K071890 | 000 |
| 00844856002777 | K071890 | 000 |
| 00844856002760 | K071890 | 000 |
| 00844856002753 | K071890 | 000 |
| 00844856002746 | K071890 | 000 |
| 00844856002739 | K071890 | 000 |
| 00844856001800 | K071890 | 000 |
| 00844856003897 | K071890 | 000 |
| 00844856003903 | K071890 | 000 |
| 00844856024403 | K071890 | 000 |
| 00844856024397 | K071890 | 000 |
| 00844856024380 | K071890 | 000 |
| 00844856024373 | K071890 | 000 |
| 00844856024366 | K071890 | 000 |
| 00844856024359 | K071890 | 000 |
| 00844856024342 | K071890 | 000 |
| 00844856024335 | K071890 | 000 |
| 00844856023543 | K071890 | 000 |
| 00844856023536 | K071890 | 000 |
| 00844856023529 | K071890 | 000 |
| 00844856023512 | K071890 | 000 |
| 00844856023505 | K071890 | 000 |
| 00844856023499 | K071890 | 000 |
| 00844856023482 | K071890 | 000 |
| 00844856023475 | K071890 | 000 |
| 00844856023468 | K071890 | 000 |
| 00844856001787 | K071890 | 000 |