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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinal Vertebral Body Replacement Device
510(k) Number K003155
Device Name VERTEBRAL BODY REPLACEMENT
Applicant
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Applicant Contact KIM THURMAN
Correspondent
Osteotech, Inc.
51 James Way
Eatontown,  NJ  07724
Correspondent Contact KIM THURMAN
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/10/2000
Decision Date 01/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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