510(k) K130655 ยท OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
RESPONSE SPINE SYSTEM
| Applicant | OrthoPediatrics Corp., Warsaw IN, US |
| Decision | Substantially Equivalent, May 8, 2013 |
| Received | Mar 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130655
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.