The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Finn Knee Prosthesis.
| Device ID | K910877 |
| 510k Number | K910877 |
| Device Name: | FINN KNEE PROSTHESIS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Contact | Patricia M Sandborn |
| Correspondent | Patricia M Sandborn BIOMET, INC. P.O. BOX 587 AIRPORT INDUSTRIAL PARK Warsaw, IN 46581 -0587 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-01 |
| Decision Date | 1991-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304649293 | K910877 | 000 |
| 00880304006126 | K910877 | 000 |
| 00880304006140 | K910877 | 000 |
| 00880304006164 | K910877 | 000 |
| 00880304006171 | K910877 | 000 |
| 00880304006218 | K910877 | 000 |
| 00880304006263 | K910877 | 000 |
| 00880304006270 | K910877 | 000 |
| 00880304006317 | K910877 | 000 |
| 00880304244030 | K910877 | 000 |
| 00880304244054 | K910877 | 000 |
| 00880304244078 | K910877 | 000 |
| 00880304244146 | K910877 | 000 |
| 00880304244290 | K910877 | 000 |
| 00880304244306 | K910877 | 000 |
| 00880304006102 | K910877 | 000 |