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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 K100575
Device Name LDR SPINE USA SPINE TUNE TL SPINE SYSTEM
Applicant
Ldr Spine USA
4030 W. Braker Ln.
Suite 360
Austin,  TX  78759
Applicant Contact NOAH BARTSCH
Correspondent
Ldr Spine USA
4030 W. Braker Ln.
Suite 360
Austin,  TX  78759
Correspondent Contact NOAH BARTSCH
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received03/01/2010
Decision Date 03/31/2010
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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