510(k) K211770 ยท HWC Screw, Fixation, Bone
R3ACT Stabilization System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Dec 25, 2021 |
| Received | Jun 8, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211770
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.