The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2mm Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2mm Tibial Recutter.
| Device ID | K200151 |
| 510k Number | K200151 |
| Device Name: | Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Contact | Pankti Shah |
| Correspondent | Pankti Shah Zimmer, Inc. 1800 W. Center Street Warsaw, IN 46580 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-22 |
| Decision Date | 2020-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024192683 | K200151 | 000 |
| 00880304809116 | K200151 | 000 |
| 00880304809109 | K200151 | 000 |
| 00880304809093 | K200151 | 000 |
| 00880304809086 | K200151 | 000 |
| 00889024582873 | K200151 | 000 |
| 00889024582866 | K200151 | 000 |
| 00889024582859 | K200151 | 000 |
| 00889024582842 | K200151 | 000 |