The following data is part of a premarket notification filed by Biomet, Inc. with the FDA for Cobalt Bone Cement.
| Device ID | K051496 |
| 510k Number | K051496 |
| Device Name: | COBALT BONE CEMENT |
| Classification | Bone Cement |
| Applicant | BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Contact | Lonnie Witham |
| Correspondent | Lonnie Witham BIOMET, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46582 |
| Product Code | LOD |
| CFR Regulation Number | 888.3027 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-06 |
| Decision Date | 2005-08-04 |
| Summary: | summary |