510(k) K153446 ยท OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
OLYMPIC Posterior Spinal Fixation System
| Applicant | Astura Medical, Carlsbad CA, US |
| Decision | Substantially Equivalent, Apr 8, 2016 |
| Received | Nov 27, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153446
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.