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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 K042930
Device Name SPACEVISION CAGE SYSTEM
Applicant
Spine Vision, Inc.
3003 Summit Blvd., Suite 1400
Atlanta,  GA  30319
Applicant Contact LYNETTE WHITAKER
Correspondent
Spine Vision, Inc.
3003 Summit Blvd., Suite 1400
Atlanta,  GA  30319
Correspondent Contact LYNETTE WHITAKER
Regulation Number888.3060
Classification Product Code
MQP  
Date Received10/22/2004
Decision Date 12/28/2004
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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