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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 K973868
Device Name SSCS (SEGMENTAL SPINAL CORRECTION SYSTEM)
Applicant
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Applicant Contact CHRISTOPHER TALBOT
Correspondent
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Correspondent Contact CHRISTOPHER TALBOT
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received10/10/1997
Decision Date 01/08/1998
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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