510(k) K153378 ยท HWC Screw, Fixation, Bone
Monster BITE Screw System
| Applicant | Paragon 28, Englewood CO, US |
| Decision | Substantially Equivalent, Dec 21, 2015 |
| Received | Nov 23, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153378
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.