510(k) K152548 ยท HRS Plate, Fixation, Bone
AXI+LINE Proximal Bunion Correction System
| Applicant | Nextremity Solutions, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Dec 21, 2015 |
| Received | Sep 8, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152548
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.