MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM


Device Classification Name

screw, fixation, bone

510(k) Number K024060
Device Name MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale, 
NJ 
07401 -1677

Original Contact karen ariemma
Regulation Number 888.3040
Classification Product Code
HWC  
Date Received 12/09/2002
Decision Date 12/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Orthopedic

510k Review Panel

Orthopedic

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No