AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES


Device Classification Name

plate, fixation, bone

510(k) Number K112455
Device Name AIMING BLOCKS FOR VARIAX DISTAL RADIUS PLATES
Applicant
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 corporate drive
mahwah, 
NJ 
07430

Applicant Contact stephanie fitts
Correspondent
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 corporate drive
mahwah, 
NJ 
07430

Correspodent Contact stephanie fitts
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 08/25/2011
Decision Date 09/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No