The following data is part of a premarket notification filed by Astura Medical with the FDA for Olympic Posterior Spinal Fixation System.
| Device ID | K153446 |
| 510k Number | K153446 |
| Device Name: | OLYMPIC Posterior Spinal Fixation System |
| Classification | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Applicant | Astura Medical 5670 El Camino Real, Suite B Carlsbad, CA 92008 |
| Contact | Troy Taylor |
| Correspondent | J.d. Webb THE ORTHOMEDIX GROUP, INC 1001 OAKWOOD BLVD Round Rock, TX 78681 |
| Product Code | OSH |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-04-08 |
| Summary: | summary |