510(k) K931665 ยท HWC Screw, Fixation, Bone
6.5 MM CANCELLOUS BONE SCREW
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Feb 17, 1994 |
| Received | Apr 5, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 25, 2012 | Encore Medical, Lp 6.5mm Cancellous Bone Screw
Intended to be used for the fixation of the acetabular shell or fracture repair. Terminated |
HWC | None listed |
| Aug 6, 2012 | Encore Medical, Lp djo surgical Screw 6.5 mm, Sz 25mm, low profile.
Product is intended for the fixation of the acetabular shell or fracture repair Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.