The following data is part of a premarket notification filed by Alphatec Spine, Inc. with the FDA for Zodiac Dynamo Semi-rigid Spinal System.
| Device ID | K072081 |
| 510k Number | K072081 |
| Device Name: | ZODIAC DYNAMO SEMI-RIGID SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| 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 | KWP |
| 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 | 2007-07-30 |
| Decision Date | 2007-10-24 |
| Summary: | summary |