The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Cobalt V Radiopaque Vertebroplasty Bone Cement.
| Device ID | K070015 |
| 510k Number | K070015 |
| Device Name: | COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT |
| Classification | Bone Cement |
| Applicant | BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Gary E Baker, Ms Rac |
| Correspondent | Gary E Baker, Ms Rac 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 | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-11-30 |
| Summary: | summary |