The following data is part of a premarket notification filed by Zimmer Inc. with the FDA for Persona Natural Tibia Baseplates.
| Device ID | K122765 |
| 510k Number | K122765 |
| Device Name: | PERSONA NATURAL TIBIA BASEPLATES |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Contact | Nicole J Meredith |
| Correspondent | Nicole J Meredith ZIMMER INC. P.O. BOX 708 Warsaw, IN 46581 -0708 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-10 |
| Decision Date | 2012-11-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024247598 | K122765 | 000 |
| 00889024247277 | K122765 | 000 |
| 00889024478688 | K122765 | 000 |
| 00889024478695 | K122765 | 000 |
| 00889024478701 | K122765 | 000 |
| 00889024478718 | K122765 | 000 |
| 00889024478725 | K122765 | 000 |
| 00889024478732 | K122765 | 000 |
| 00889024478671 | K122765 | 000 |
| 00889024247291 | K122765 | 000 |
| 00889024630666 | K122765 | 000 |