VARIAX ELBOW SYSTEM


Device Classification Name

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

510(k) Number K073527
Device Name VARIAX ELBOW SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Applicant Contact francisco haro
Correspondent
HOWMEDICA OSTEONICS CORP
325 corporate dr.
mahwah, 
NJ 
07430

Correspodent Contact francisco haro
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 12/17/2007
Decision Date 02/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No