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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K981452
Device Name OSTEONICS LONG ARM CONTAINMENT RING
Applicant
Osteonics Corp.
59 Route 17
Allendale,,  NJ  07401 -1677
Applicant Contact KATE SUTTON
Correspondent
Osteonics Corp.
59 Route 17
Allendale,,  NJ  07401 -1677
Correspondent Contact KATE SUTTON
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received04/22/1998
Decision Date 05/20/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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