510(k) K912245 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
AGC REVISION KNEE PROTHESIS
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent for Some Indications, Aug 19, 1991 |
| Received | May 21, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912245
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2020 | Biomet, Inc. RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Product Usage: Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented; Prosthesis, Hip, Semi-Const Terminated |
LPH | None listed |
| Mar 1, 2019 | Zimmer Biomet, Inc. Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx20mm-Low Profile Titanium. Accessory to total hip implant
Item Number: 103531
Product Usage:
Accessory to total hip implant Terminated |
JWH | None listed |
| Mar 1, 2019 | Zimmer Biomet, Inc. Biomet RingLoc Hip System Self-Tapping Bone Screw 6.5mmx30mm-Low Profile Titanium, Accessory to total hip implant
Item Number: 103533
Product Usage:
Accessory to total hip implant Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.