AXSOS DISTAL LATERAL FEMUR TS LONG PLATES


Device Classification Name

plate, fixation, bone

510(k) Number K122308
Device Name AXSOS DISTAL LATERAL FEMUR TS LONG PLATES
Applicant
HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS
325 corporate drive
mahwah, 
NJ 
07430

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

Correspodent Contact stephanie m fitts
Regulation Number 888.3030
Classification Product Code
HRS  
Date Received 08/01/2012
Decision Date 10/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No