DEPUY ATTUNE TOTAL KNEE SYSTEM


Device Classification Name

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

510(k) Number K103756
Device Name DEPUY ATTUNE TOTAL KNEE SYSTEM
Applicant
DEPUY ORTHOPAEDICS, INC.
700 orthopaedic drive
warsaw, 
IN 
46581 -0988

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

Correspodent Contact nancy friddle
Regulation Number 888.3560
Classification Product Code
OIY  
Subsequent Product Code
JWH  
Date Received 12/23/2010
Decision Date 03/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No