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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Evoked Response
510(k) Number K182542
Device Name The EPAD 2 System
Applicant
Safeop Surgical, Inc.
11350 Mccormick Rd., Suite 1003
Hunt Valley,  MD  21031
Applicant Contact Richard O'Brien
Correspondent
Alphatec Spine, Inc.
5818 El Camino Real
Carlsnad,  CA  92008
Correspondent Contact Jeremy Markovich
Regulation Number882.1870
Classification Product Code
GWF  
Subsequent Product Codes
ETN   GXY   GXZ   IKN   PDQ  
Date Received09/17/2018
Decision Date 02/22/2019
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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