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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 K991586
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 Codes
MNH   MNI  
Date Received05/07/1999
Decision Date 07/23/1999
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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