The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Orthopedic Salvage System (oss) 9cm Cobalt - Chrome Tibial Bodies.
| Device ID | K083827 |
| 510k Number | K083827 |
| Device Name: | ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | BIOMET MANUFACTURING CORP. PO BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary Baker |
| Correspondent | Gary Baker BIOMET MANUFACTURING CORP. 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 | 2008-12-23 |
| Decision Date | 2009-02-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304840416 | K083827 | 000 |
| 00880304652217 | K083827 | 000 |
| 00880304652200 | K083827 | 000 |
| 00880304652194 | K083827 | 000 |
| 00880304510081 | K083827 | 000 |