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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 K043479
Device Name MC+ PARTIAL VBR
Applicant
Ldr Spine USA
4030 W. Braker Ln.
Suite 360
Austin,  TX  78759
Applicant Contact BRIAN BURKINSHAW
Correspondent
Ldr Spine USA
4030 W. Braker Ln.
Suite 360
Austin,  TX  78759
Correspondent Contact BRIAN BURKINSHAW
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/16/2004
Decision Date 06/30/2005
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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