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 |