The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Reduced Size Oncology Salvage System.
| Device ID | K021260 |
| 510k Number | K021260 |
| Device Name: | REDUCED SIZE ONCOLOGY SALVAGE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET, INC. 56 EAST BELL DR. Warsaw, IN 46581 -0587 |
| Contact | Sara B Shultz |
| Correspondent | Sara B Shultz BIOMET, 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 | 2002-04-19 |
| Decision Date | 2002-06-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304554726 | K021260 | 000 |
| 00880304250895 | K021260 | 000 |
| 00880304250888 | K021260 | 000 |
| 00880304250833 | K021260 | 000 |
| 00880304250826 | K021260 | 000 |
| 00880304250819 | K021260 | 000 |
| 00880304250802 | K021260 | 000 |
| 00880304250772 | K021260 | 000 |
| 00880304250765 | K021260 | 000 |
| 00880304250758 | K021260 | 000 |
| 05019279057580 | K021260 | 000 |
| 00880304250901 | K021260 | 000 |
| 00880304250918 | K021260 | 000 |
| 00880304554719 | K021260 | 000 |
| 00880304554702 | K021260 | 000 |
| 00880304481138 | K021260 | 000 |
| 00880304481121 | K021260 | 000 |
| 00880304467989 | K021260 | 000 |
| 00880304250963 | K021260 | 000 |
| 00880304250956 | K021260 | 000 |
| 00880304250949 | K021260 | 000 |
| 00880304250932 | K021260 | 000 |
| 00880304250925 | K021260 | 000 |
| 00887868343940 | K021260 | 000 |