TOTAL KNEE CEMENTED, SEMI-CONSTRAINED


Device Classification Name

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

510(k) Number K021740
Device Name TOTAL KNEE CEMENTED, SEMI-CONSTRAINED
Original Applicant
DJ ORTHOPEDICS, LLC
2985 scott st.
vista, 
CA 
92083

Original Contact nora c.r. york
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 05/28/2002
Decision Date 09/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No