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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 K083353
Device Name CAPSURE(R) PS SYSTEM
Applicant
Spine Wave, Inc.
Two Enterprise Dr.
Suite 302
Shelton,  CT  06484
Applicant Contact ROAIDA RIZKALLAH
Correspondent
Spine Wave, Inc.
Two Enterprise Dr.
Suite 302
Shelton,  CT  06484
Correspondent Contact ROAIDA RIZKALLAH
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received11/13/2008
Decision Date 12/11/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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