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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K121924
Device Name INTEGRA INTERSPINOUS PROCESS SYSTEM
Applicant
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Applicant Contact NICK M CORDARO
Correspondent
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Correspondent Contact NICK M CORDARO
Regulation Number888.3050
Classification Product Code
PEK  
Date Received07/02/2012
Decision Date 09/04/2013
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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