VARIAX DISTAL RADIUS TORX SCREWS


Device Classification Name

plate, fixation, bone

510(k) Number K080667
Device Name VARIAX DISTAL RADIUS TORX SCREWS
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact danielle hillman
Correspondent
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact danielle hillman
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 03/10/2008
Decision Date 03/19/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No