DEPUY SIGMA PS FEMORAL COMPONENTS


Device Classification Name

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

510(k) Number K073529
Device Name DEPUY SIGMA PS FEMORAL COMPONENTS
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
JWH  
Date Received 12/17/2007
Decision Date 01/24/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No