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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 K183080
Device Name Mega Plus Spine System
Applicant
Bk Meditech, Co., Ltd.
58, Eunhaengnamu-Ro, Yanggam-Myeon,
Hwaseong-Si,  KR 18633
Applicant Contact Meredith Lee May
Correspondent
Empirical Testing Corp
4628 Northpark Dr.
Colorado Springs,  CO  80918
Correspondent Contact Meredith L. May
Regulation Number888.3070
Classification Product Code
NKB  
Date Received11/05/2018
Decision Date 12/10/2018
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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