The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Repicci Ii Unicondylar Knee System.
| Device ID | K020264 |
| 510k Number | K020264 |
| Device Name: | REPICCI II UNICONDYLAR KNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Dalene T Binkley |
| Correspondent | Dalene T Binkley BIOMET ORTHOPEDICS, INC. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-25 |
| Decision Date | 2002-02-08 |
| Summary: | summary |