Panels › Orthopedic › Product code PBI · Class 2
Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
Regulation 888.3310
0510(k)s in 12 months (2 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in PBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet, Inc. | 0 | 2 |
| Biomet Manufacturing Corp | 1 | 0 |
| Zimmer, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 28, 2022 | K212512 | G7® Vivacit-E® Freedom® Constrained Liner Zimmer, Inc. | PBI |
| Nov 23, 2012 | K121874 | G7 ACETABULAR SYSTEM Biomet Manufacturing Corp | PBI |
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