510(k) K162241 · PLF Bone Wedge
TITAN 3-D Wedge System
| Applicant | Paragon 28, Englewood CO, US |
| Decision | Substantially Equivalent, Apr 3, 2017 |
| Received | Aug 10, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162241
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2019 | Paragon 28, Inc. P28, Titan 3-D Wedge, Evans, Large, 10 mm, sterile, REF P03-EVN-1010-S, Type: Lagrge, Size: 10mm, (01) 00889795018182, Sterile R, Single Use Only Terminated |
PLF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.