510(k) K131615 ยท OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
POLARIS SPINAL SYSTEM
| Applicant | Biomet Spine (Aka Ebi, LLC), Parsippany NJ, US |
| Decision | Substantially Equivalent, Sep 4, 2013 |
| Received | Jun 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131615
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.