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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 K070295
Device Name SINGLE PLANAR MULTI AXIAL (SPMA) PEDICLE SCREW SYSTEM
Applicant
TRINITY ORTHOPEDICS, LLC
11234 EL CAMINO REAL, SUITE 20
san diego,,  CA  92130
Applicant Contact floyd g larson
Correspondent
TRINITY ORTHOPEDICS, LLC
11234 EL CAMINO REAL, SUITE 20
san diego,,  CA  92130
Correspondent Contact floyd g larson
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received01/31/2007
Decision Date 05/21/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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