The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Oss-bodies Proximal Tibial Sleeve.
| Device ID | K060131 |
| 510k Number | K060131 |
| Device Name: | OSS-BODIES PROXIMAL TIBIAL SLEEVE |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Tracy Bickel Johnson |
| Correspondent | Tracy Bickel Johnson BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE PO BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-01-18 |
| Decision Date | 2006-02-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304479340 | K060131 | 000 |
| 00880304463721 | K060131 | 000 |
| 00880304463714 | K060131 | 000 |
| 00880304463707 | K060131 | 000 |