COHESION BONE CEMENT


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K103816
Device Name COHESION BONE CEMENT
Applicant
TEKNIMED, S.A.S.
1001 oakwood blvd
round rock, 
TX 
78681

Applicant Contact j. d webb
Correspondent
TEKNIMED, S.A.S.
1001 oakwood blvd
round rock, 
TX 
78681

Correspodent Contact j. d webb
Regulation Number 888.3027
Classification Product Code
NDN  
Date Received 12/29/2010
Decision Date 02/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No