VARIAX DISTAL FIBULA PLATE


Device Classification Name

appliance, fixation, nail/blade/plate combination, multiple component

510(k) Number K081284
Device Name VARIAX DISTAL FIBULA PLATE
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact andrea m dwyer
Correspondent
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact andrea m dwyer
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 05/06/2008
Decision Date 07/18/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No