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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K964544
Device Name OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY
Applicant
Osteonics Corp.
59 Route 17
Allendale,,  NJ  07401 -1677
Applicant Contact DONNA S WILSON
Correspondent
Osteonics Corp.
59 Route 17
Allendale,,  NJ  07401 -1677
Correspondent Contact DONNA S WILSON
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received11/13/1996
Decision Date 02/11/1997
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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