T2 SUPRACONDYLAR NAIL SYSTEM


Device Classification Name

rod, fixation, intramedullary and accessories

510(k) Number K023267
Device Name T2 SUPRACONDYLAR NAIL SYSTEM
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 09/30/2002
Decision Date 12/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No