510(k) K190586 · HWC Screw, Fixation, Bone
Monster® Screw System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Apr 3, 2019 |
| Received | Mar 6, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190586
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.