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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 K024060
FOIA Releasable 510(k) K024060
Device Name MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM
Applicant
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Applicant Contact KAREN ARIEMMA
Correspondent
HOWMEDICA OSTEONICS CORP.
59 ROUTE 17 SOUTH
ALLENDALE,  NJ  07401 -1677
Correspondent Contact KAREN ARIEMMA
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/09/2002
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
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