OPACITY + BONE CEMENT


Device Classification Name

cement, bone, vertebroplasty

510(k) Number K080873
Device Name OPACITY + BONE CEMENT
Applicant
TEKNIMED SA
1001 oakwood blvd
round rock, 
TX 
78681

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

Correspodent Contact j.d. webb
Regulation Number 888.3027
Classification Product Code
NDN  
Date Received 03/31/2008
Decision Date 08/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No