510(k) K122738 ยท HWC Screw, Fixation, Bone
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
| Applicant | Solana Surgical, LLC, Memphis TN, US |
| Decision | Substantially Equivalent, Nov 7, 2012 |
| Received | Sep 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122738
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.