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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 K132740
Device Name SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM
Applicant
Spinefrontier, Inc.
500 Cummings Center, Suite 3500
Beverly,  MA  01915
Applicant Contact PAUL L SPEIDEL
Correspondent
Spinefrontier, Inc.
500 Cummings Center, Suite 3500
Beverly,  MA  01915
Correspondent Contact PAUL L SPEIDEL
Regulation Number888.3050
Classification Product Code
NQW  
Date Received09/03/2013
Decision Date 11/26/2013
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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