The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for G7® Vivacit-e® Freedom® Constrained Liner.
| Device ID | K212512 |
| 510k Number | K212512 |
| Device Name: | G7® Vivacit-E® Freedom® Constrained Liner |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer, + Additive |
| Applicant | Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Contact | Romil Sheth |
| Correspondent | Adam Haas Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Product Code | PBI |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-10 |
| Decision Date | 2022-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024588639 | K212512 | 000 |
| 00889024588486 | K212512 | 000 |
| 00889024588479 | K212512 | 000 |
| 00889024588462 | K212512 | 000 |
| 00889024588455 | K212512 | 000 |
| 00889024588448 | K212512 | 000 |
| 00889024588431 | K212512 | 000 |
| 00889024588424 | K212512 | 000 |
| 00889024588417 | K212512 | 000 |
| 00889024588400 | K212512 | 000 |
| 00889024588394 | K212512 | 000 |
| 00889024588387 | K212512 | 000 |
| 00889024588493 | K212512 | 000 |
| 00889024588509 | K212512 | 000 |
| 00889024588516 | K212512 | 000 |
| 00889024588622 | K212512 | 000 |
| 00889024588615 | K212512 | 000 |
| 00889024588608 | K212512 | 000 |
| 00889024588592 | K212512 | 000 |
| 00889024588585 | K212512 | 000 |
| 00889024588578 | K212512 | 000 |
| 00889024588561 | K212512 | 000 |
| 00889024588554 | K212512 | 000 |
| 00889024588547 | K212512 | 000 |
| 00889024588530 | K212512 | 000 |
| 00889024588523 | K212512 | 000 |
| 00889024588370 | K212512 | 000 |