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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 K964304
Device Name OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY
Applicant
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Applicant Contact DONNA S WILSON
Correspondent
Osteonics Corp.
59 Rte. 17
Allendale,  NJ  07401
Correspondent Contact DONNA S WILSON
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
KWP  
Date Received10/29/1996
Decision Date 01/17/1997
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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