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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K181606
Device Name Precision Spine Navigation Instrumentation
Applicant
Precision Spine, Inc.
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact Michael C. Dawson
Correspondent
Empirical Consulting
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/19/2018
Decision Date 09/27/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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