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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 K042201
Device Name NOVEL VBR SPINAL SYSTEM
Applicant
Alphatec/Nexmed
6110 Corte Del Cedro
Carlsbad,  CA  92009
Applicant Contact ELLEN YARNALL
Correspondent
Alphatec/Nexmed
6110 Corte Del Cedro
Carlsbad,  CA  92009
Correspondent Contact ELLEN YARNALL
Regulation Number888.3060
Classification Product Code
MQP  
Date Received08/13/2004
Decision Date 10/07/2004
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
Recalls CDRH Recalls
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