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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K043094
Device Name EASYSPINE SYSTEM
Applicant
Ldr Spine USA
4030 W. Braker Lane
Suite 360
Austin,  TX  78759
Applicant Contact BRIAN BURKINSHAW
Correspondent
Ldr Spine USA
4030 W. Braker Lane
Suite 360
Austin,  TX  78759
Correspondent Contact BRIAN BURKINSHAW
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received11/09/2004
Decision Date 02/11/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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