510(k) K231231 ยท HWC Screw, Fixation, Bone
MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Oct 12, 2023 |
| Received | Apr 28, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K231231
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.