510(k) K190365 ยท HRS Plate, Fixation, Bone
Baby Gorilla/Gorilla Plating System
| Applicant | Paragon 28, Inc., Englewood CO, US |
| Decision | Substantially Equivalent, Apr 12, 2019 |
| Received | Feb 15, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190365
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.