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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 K132154
Device Name CAPSURE PS SYSTEM
Applicant
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact JOSEPH MERCADO
Correspondent
Spine Wave, Inc.
Three Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact JOSEPH MERCADO
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received07/12/2013
Decision Date 08/09/2013
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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