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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K121103
Device Name LDR SPINE USA SPINE TUNE, TL SPINAL SYSTEM, LDR SPINE USA EASYSPINE, POSTERIOR SPINAL SYSTEM, LDR SPINE USA MC IMPLANT S
Applicant
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Applicant Contact BRADLEY W STRASSER
Correspondent
Ldr Spine USA, Inc.
13785 Research Blvd., Suite 200
Austin,  TX  78750
Correspondent Contact BRADLEY W STRASSER
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
KWP   MAX   MNH   MNI   MQP  
ODP   OVD   OVE  
Date Received04/11/2012
Decision Date 08/24/2012
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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