The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Repicci Ii Unicondylar Knee.
Device ID | K971938 |
510k Number | K971938 |
Device Name: | REPICCI II UNICONDYLAR KNEE |
Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
Applicant | BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Contact | Patricia Sandborn Beres |
Correspondent | Patricia Sandborn Beres BIOMET, INC. AIRPORT INDUSTRIAL PARK, P.O.BOX 587 Warsaw, IN 46581 -0587 |
Product Code | HRY |
CFR Regulation Number | 888.3530 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-05-27 |
Decision Date | 1997-08-25 |
Summary: | summary |