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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 K083857
Device Name LDR SPINE ROI-C IMPLANT
Applicant
Ldr Spine USA
4030 W. Braker Lane
Suite 360
Austin,  TX  78759
Applicant Contact NOAH BARTSCH
Correspondent
Ldr Spine USA
4030 W. Braker Lane
Suite 360
Austin,  TX  78759
Correspondent Contact NOAH BARTSCH
Regulation Number888.3060
Classification Product Code
MQP  
Date Received12/24/2008
Decision Date 02/12/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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