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 |