The following data is part of a premarket notification filed by Biomet Manufacturing, Inc. with the FDA for Rs (reduced Size) Oss (orthopedic Salvage System) Additional Components.
| Device ID | K051479 |
| 510k Number | K051479 |
| Device Name: | RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET MANUFACTURING, INC. 56 EAST BELL DR. 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 | 2005-06-03 |
| Decision Date | 2005-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304649323 | K051479 | 000 |
| 00880304250987 | K051479 | 000 |
| 00880304250970 | K051479 | 000 |
| 00880304250871 | K051479 | 000 |
| 00880304250864 | K051479 | 000 |
| 00880304250857 | K051479 | 000 |
| 00880304250840 | K051479 | 000 |
| 00880304250796 | K051479 | 000 |
| 00880304250789 | K051479 | 000 |
| 00880304250741 | K051479 | 000 |
| 00880304250734 | K051479 | 000 |
| 00880304250727 | K051479 | 000 |
| 00880304250710 | K051479 | 000 |
| 00880304250994 | K051479 | 000 |
| 00880304469310 | K051479 | 000 |
| 00880304500983 | K051479 | 000 |
| 00880304649316 | K051479 | 000 |
| 00880304554740 | K051479 | 000 |
| 00880304554733 | K051479 | 000 |
| 00880304549937 | K051479 | 000 |
| 00880304549920 | K051479 | 000 |
| 00880304549913 | K051479 | 000 |
| 00880304549906 | K051479 | 000 |
| 00880304549890 | K051479 | 000 |
| 00880304549883 | K051479 | 000 |
| 00880304509702 | K051479 | 000 |
| 00880304507548 | K051479 | 000 |
| 00880304505216 | K051479 | 000 |
| 00880304250703 | K051479 | 000 |