510(k) K121874 ยท PBI Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
G7 ACETABULAR SYSTEM
| Applicant | Biomet Manufacturing Corp, Warsaw IN, US |
| Decision | Substantially Equivalent, Nov 23, 2012 |
| Received | Jun 27, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121874
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 5, 2022 | Zimmer, Inc. G7 Acetabular System, Acetabular Shell, Item numbers Item Numbers: 010000663 (52 MM E), 010000667 (60 MM G). used in hip arthroplasty Open, Classified |
OQI | None listed |
| Jun 19, 2014 | Biomet, Inc. G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110003458. Terminated |
PBI | None listed |
| Jun 19, 2014 | Biomet, Inc. G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:110003500. Terminated |
PBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.