510(k) K191641 · HRS Plate, Fixation, Bone
AFFINITY Variable Angle Distal Radius System, AFFINITY Variable Angle Distal Radius Plates, AFFINITY Variable Angle Distal Radius Screws
| Applicant | Industrias Medicas Sampedro S.A.S, La Estrella, CO |
| Decision | Substantially Equivalent, Sep 16, 2019 |
| Received | Jun 19, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191641
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.