VBB SYSTEM


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K110604
Device Name VBB SYSTEM
Applicant
SYNTHES
1302 wrights lane east
west chester, 
PA 
19380

Applicant Contact jason lipman
Correspondent
SYNTHES
1302 wrights lane east
west chester, 
PA 
19380

Correspodent Contact jason lipman
Regulation Number 888.3027
Classification Product Code
NDN  
Subsequent Product Code
HRX  
Date Received 03/03/2011
Decision Date 12/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls