OMEGA 3 TROCHANTERIC STABILIZING PLATE


Device Classification Name

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

510(k) Number K081278
Device Name OMEGA 3 TROCHANTERIC STABILIZING PLATE
Applicant
HOWMEDICA OSTEONICS CORP.
325 corporate drive
mahwah, 
NJ 
07430

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

Correspodent Contact andrea dwyer
Regulation Number 888.3030
Classification Product Code
KTT  
Date Received 05/06/2008
Decision Date 05/29/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No