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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name screw, fixation, bone
510(k) Number K000080
Device Name ASNIS III CANNULATED SCREW SYSTEM
Original Applicant
HOWMEDICA OSTEONICS CORP.
59 route 17 south
allendale,  NJ  07401 -1677
Original Contact mary-catherine dillon
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HTN  
Date Received01/11/2000
Decision Date 04/03/2000
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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