510(k) K971755 ยท JEC Component, Traction, Invasive
HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent, Jul 17, 1997 |
| Received | May 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Stryker Howmedica Osteonics Corp. Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures. Terminated |
JEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.