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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 K042713
Device Name FIDJI-VERTEBRAL BODY REPLACEMENT TYPE 5
Applicant
Spine Next America Corporation
8381 Dix Ellis Trl., Suite 110
Jacksonville,  FL  32256
Applicant Contact TOM BREWER
Correspondent
Spine Next America Corporation
8381 Dix Ellis Trl., Suite 110
Jacksonville,  FL  32256
Correspondent Contact TOM BREWER
Regulation Number888.3060
Classification Product Code
MQP  
Date Received09/30/2004
Decision Date 12/29/2004
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
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