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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 K063794
Device Name MODIFICATION TO EASYSPINE SYSTEM
Applicant
LDR SPINE USA
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Applicant Contact floyd g larson
Correspondent
LDR SPINE USA
11234 EL CAMINO REAL
SUITE 200
san diego,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received12/22/2006
Decision Date 01/24/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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