SMARTSET MV BONE CEMENT


Device Classification Name

bone cement

510(k) Number K081155
Device Name SMARTSET MV BONE CEMENT
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Applicant Contact suzana otano
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Correspodent Contact suzana otano
Regulation Number 888.3027
Classification Product Code
LOD  
Date Received 04/23/2008
Decision Date 05/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No