510(k) K170923 ยท JDR Staple, Fixation, Bone
JAWS(TM) Nitinol Staple System
| Applicant | Paragon 28, Englewood CO, US |
| Decision | Substantially Equivalent, Jul 24, 2017 |
| Received | Mar 29, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170923
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2017 | Paragon 28, Inc. P28 JAWS Nitinol Staple System kits are designed for use in an osteotomy, arthrodesis and fragment fixation of bones and joints of the foot including fixation of small bone fragments. Terminated |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.