SMARTSET GMV GENTAMICIN BONE CEMENT


Device Classification Name

bone cement, antibiotic

510(k) Number K081163
Device Name SMARTSET GMV GENTAMICIN 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
MBB  
Subsequent Product Code
LOD  
Date Received 04/24/2008
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

Yes