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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 K081790
Device Name MODIFICATION TO SINGLE PLANAR MULTI AXIS (SPMA) PEDICLE SCREW SYSTEM
Applicant
TRINITY ORTHOPEDICS, LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Applicant Contact KEVIN A THOMAS
Correspondent
TRINITY ORTHOPEDICS, LLC
11234 EL CAMINO REAL
SUITE 200
SAN DIEGO,  CA  92130
Correspondent Contact KEVIN A THOMAS
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received06/25/2008
Decision Date 07/24/2008
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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