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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical
510(k) Number K113559
Device Name LDR SPINE CERVICAL INTERBODY FUSION SYSTME-ROI-C LORDOTIC IMPLANTS
Applicant
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Applicant Contact KIERSTEN SODERMAN
Correspondent
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Correspondent Contact KIERSTEN SODERMAN
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
OVE  
Date Received12/01/2011
Decision Date 12/29/2011
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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