COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT

Bone Cement

BIOMET MANUFACTURING CORP.

The following data is part of a premarket notification filed by Biomet Manufacturing Corp. with the FDA for Cobalt V Radiopaque Vertebroplasty Bone Cement.

Pre-market Notification Details

Device IDK070015
510k NumberK070015
Device Name:COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
ClassificationBone Cement
Applicant BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
ContactGary E Baker, Ms Rac
CorrespondentGary E Baker, Ms Rac
BIOMET MANUFACTURING CORP. 56 EAST BELL DRIVE P.O. BOX 587 Warsaw,  IN  46581 -0587
Product CodeLOD  
CFR Regulation Number888.3027 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-01-03
Decision Date2007-11-30
Summary:summary

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