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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K140219
Device Name PICASSO II MIS SPINAL SYSTEM
Applicant
Accel Spine
14001 Hunters Pass
Austin,  TX  78734
Applicant Contact LISA PETERSON
Correspondent
Accel Spine
14001 Hunters Pass
Austin,  TX  78734
Correspondent Contact LISA PETERSON
Regulation Number888.3070
Classification Product Code
NKB  
Subsequent Product Codes
MNH   MNI  
Date Received01/29/2014
Decision Date 04/14/2014
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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