TRUMATCH PERSONALIZED SOLUTIONS


Device Classification Name

prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer

510(k) Number K110397
Device Name TRUMATCH PERSONALIZED SOLUTIONS
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Applicant Contact nancy s friddle
Correspondent
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

Correspodent Contact nancy s friddle
Regulation Number 888.3560
Classification Product Code
JWH  
Subsequent Product Code
OOG  
Date Received 02/11/2011
Decision Date 08/16/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No