510(k) K191412 ยท HRS Plate, Fixation, Bone
VariAx 2 System, VariAx 2 Mini Fragment System
| Applicant | Stryker GmbH, Mahwah NJ, US |
| Decision | Substantially Equivalent, Aug 23, 2019 |
| Received | May 28, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191412
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.