COLUMBUS (CR) TOTAL KNEE SYSTEM


Device Classification Name

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

510(k) Number K023788
Device Name COLUMBUS (CR) TOTAL KNEE SYSTEM
Original Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Original Contact joyce kilroy
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 11/13/2002
Decision Date 12/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No