MODIFICATION TO TRIATHLON TS KNEE SYSTEM


Device Classification Name

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

510(k) Number K072221
Device Name MODIFICATION TO TRIATHLON TS KNEE SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate dr
mahwah, 
NJ 
07430

Applicant Contact tiffani rogers
Correspondent
HOWMEDICA OSTEONICS CORP.
325 corporate dr
mahwah, 
NJ 
07430

Correspodent Contact tiffani rogers
Regulation Number 888.3560
Classification Product Code
JWH  
Date Received 08/10/2007
Decision Date 10/15/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No