T2 FEMORAL NAIL


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K010801
Device Name T2 FEMORAL NAIL
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact karen ariemma
Regulation Number 888.3020
Classification Product Code
HSB  
Date Received 03/16/2001
Decision Date 04/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

Type Special
Reviewed by Third Party No

Combination Product

No