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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K102020
Device Name VEGA SPAN SPINOUS PROCESS PLATE SYSTEM
Applicant
Spinefrontier, Inc.
500 Cummings Center, Suite 3500
Beverly,  MA  01915
Applicant Contact JOHN SULLIVAN
Correspondent
Spinefrontier, Inc.
500 Cummings Center, Suite 3500
Beverly,  MA  01915
Correspondent Contact JOHN SULLIVAN
Regulation Number888.3050
Classification Product Code
KWP  
Date Received07/19/2010
Decision Date 09/01/2010
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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