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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Plate, Fixation, Bone
510(k) Number K982553
Device Name OSTEO COMPRESSION HIP SCREW SYSTEM
Applicant
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Applicant Contact MARYBETH NAUGHTON
Correspondent
OSTEONICS CORP.
59 ROUTE 17
ALLENDALE,  NJ  07401 -1677
Correspondent Contact MARYBETH NAUGHTON
Regulation Number888.3030
Classification Product Code
HRS  
Subsequent Product Code
HWC  
Date Received07/22/1998
Decision Date 09/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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