The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Cobalt Mv Bone Cement.
| Device ID | K091608 |
| 510k Number | K091608 |
| Device Name: | COBALT MV BONE CEMENT |
| Classification | Bone Cement |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-03 |
| Decision Date | 2009-09-17 |
| Summary: | summary |