510(k) K991807 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
TITANIUM LOW PROFILE SCREWS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Jul 8, 1999 |
| Received | May 26, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991807
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. Custom Cancellous Thread, Item numbers CP161941,
CP161943 - Product Usage: 1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis 3. C Terminated |
LPH | None listed |
| May 3, 2011 | Biomet, Inc. Low Profile Self-Tapping Bone Screw, 6.5 mm X 25 mm, Qty. 1, Biomet Orthopedics, 66 East Bell Drive, P.O. Box 587, Warsaw, IN 46581 USA. STERILE.
To provide fixation of any acetabular cup, with appro Terminated |
HWD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.