K153446 is an FDA 510(k) clearance for the OLYMPIC Posterior Spinal Fixation System. This device is classified as a Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis (Class II - Special Controls, product code OSH).
Submitted by Astura Medical (Carlsbad, US). The FDA issued a Cleared decision on April 8, 2016, 133 days after receiving the submission on November 27, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3070. Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis..
| 510(k) Number | K153446 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2015 |
| Decision Date | April 08, 2016 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OSH — Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3070 |
| Definition | Intended To Stabilize The Thoracolumbar Spine As An Adjunct To Fusion Using Allograft And/or Autograft To Treat Adolescent Idiopathic Scoliosis. |