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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
FOIA Releasable 510(k) K000080
Device Name ASNIS III CANNULATED SCREW SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Applicant Contact MARY-CATHERINE DILLON
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Correspondent 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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