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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thoracolumbosacral Pedicle Screw System
510(k) Number K173130
Device Name Reform® Midline Cortical Screw System
Applicant
Precision Spine, Inc.
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact Michael C. Dawson
Correspondent
Empirical Technologies
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith L. May
Regulation Number888.3070
Classification Product Code
NKB  
Date Received09/29/2017
Decision Date 12/19/2017
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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