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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Retractor, Self-Retaining, For Neurosurgery
510(k) Number K161680
Device Name MEDICON Spinal Spreading Systems
Applicant
MEDICON EG
GANSACKER 15
TUTTLINGEN,  DE 78532
Applicant Contact Joachim Schmid
Correspondent
THE ORTHOMEDIX GROUP, INC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J. D. Webb
Regulation Number882.4800
Classification Product Code
GZT  
Date Received06/17/2016
Decision Date 03/24/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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