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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Facet Screw Spinal Device
510(k) Number K132859
Device Name INTEGRA FACET FIXATION SYSTEM
Applicant
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081 -7862
Applicant Contact MICHELLE WILLIS
Correspondent
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081 -7862
Correspondent Contact MICHELLE WILLIS
Classification Product Code
MRW  
Date Received09/12/2013
Decision Date 11/18/2013
Decision Substantially Equivalent (SESE)
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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