The following data is part of a premarket notification filed by Depuy, Inc. with the FDA for Alvine Total Ankle.
| Device ID | K920802 |
| 510k Number | K920802 |
| Device Name: | ALVINE TOTAL ANKLE |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Contact | Kavid A Kotkovetz |
| Correspondent | Kavid A Kotkovetz DEPUY, INC. P.O. BOX 988 Warsaw, IN 46581 -0988 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-21 |
| Decision Date | 1992-12-17 |