510(k) K162179 · HRS Plate, Fixation, Bone
osteo-WEDGE II ® Open Wedge Bone Locking Plate System
| Applicant | Graham Medical Technologies, LLC Dba Gramedica, Macomb MI, US |
| Decision | Substantially Equivalent, Jan 10, 2017 |
| Received | Aug 4, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162179
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.