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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spine, Plate, Laminoplasty, Metal
510(k) Number K150469
Device Name Integra Laminoplasty System
Applicant
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Applicant Contact MICHELLE WILLIS
Correspondent
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081
Correspondent Contact MICHELLE WILLIS
Regulation Number888.3050
Classification Product Code
NQW  
Date Received02/23/2015
Decision Date 03/23/2015
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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