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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K070341
Device Name LDR SPINE EASYSPINE POSTERIOR OSTEOSYNTHESIS SYSTEM
Applicant
Ldr Spine USA
4030 W. Braker Ln.
Suite 360
Austin,  TX  78759
Applicant Contact JAMES BURROWS
Correspondent
Ldr Spine USA
4030 W. Braker Ln.
Suite 360
Austin,  TX  78759
Correspondent Contact JAMES BURROWS
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
MNH   MNI   NKB  
Date Received02/06/2007
Decision Date 08/08/2007
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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