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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 K043349
Device Name OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI)
Applicant
LDR SPINE USA
4030 WEST BRAKER LANE
SUITE 360
AUSTIN,  TX  78759
Applicant Contact BRAIN BURKINSHAW
Correspondent
LDR SPINE USA
4030 WEST BRAKER LANE
SUITE 360
AUSTIN,  TX  78759
Correspondent Contact BRAIN BURKINSHAW
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/06/2004
Decision Date 06/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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