COLUMBUS TOTAL KNEE SYSTEM (CR)


Device Classification Name

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

510(k) Number K022672
Device Name COLUMBUS TOTAL KNEE SYSTEM (CR)
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 08/12/2002
Decision Date 11/08/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No