510(k) K990804 ยท HWC Screw, Fixation, Bone
STAYFUSE
| Applicant | Pioneer Surgical Technology, Marquette MI, US |
| Decision | Substantially Equivalent, Apr 29, 1999 |
| Received | Mar 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990804
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 27, 2004 | Pioneer Surgical Technology Stayfuse brand intramedullary bone screw; MID 3.8 x 6 mm. Zimmer part number 00-2227-003-001. Terminated |
HWC | None listed |
| Jun 21, 2003 | Pioneer Surgical Technology StayFuse PROX 03.3 MM sterile intramedullary bone screw distributed by Zimmer Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.