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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 K093127
Device Name TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET
Applicant
Zimmer Trabecular Metal Technology
10 Pomeroy Rd.
Parsippany,  NJ  07054
Applicant Contact KATHLEEN RUTHERFORD
Correspondent
Zimmer Trabecular Metal Technology
10 Pomeroy Rd.
Parsippany,  NJ  07054
Correspondent Contact KATHLEEN RUTHERFORD
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/02/2009
Decision Date 03/04/2010
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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