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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 K151863
Device Name Precision Spine Interspinous Plate System
Applicant
Precision Spine, Inc.
5 Sylvan Way
Suite 220
Parsippany,  NJ  07930
Applicant Contact MICHAEL C. DAWSON
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact KENNETH C. MAXWELL
Regulation Number888.3050
Classification Product Code
PEK  
Date Received07/08/2015
Decision Date 08/07/2015
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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