COLUMBUS (PS)


Device Classification Name

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

510(k) Number K030367
Device Name COLUMBUS (PS)
Applicant
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Applicant Contact joyce kilroy
Correspondent
AESCULAP, INC.
3773 corporate parkway
center valley, 
PA 
18034

Correspodent Contact joyce kilroy
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 02/04/2003
Decision Date 08/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No