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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 K120646
Device Name CAPSURE(R) PS SYSTEM
Applicant
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Applicant Contact ROAIDA RIZKALLAH
Correspondent
Spine Wave, Inc.
3 Enterprise Dr.
Suite 210
Shelton,  CT  06484
Correspondent Contact ROAIDA RIZKALLAH
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received03/02/2012
Decision Date 06/07/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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