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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 K173180
Device Name Mega Plus Spine System
Applicant
Bk Meditech, Co., Ltd.
58, Eunhaengnamu-Ro, Yanggam-Myeon
Hwaseong-Si,  KR
Applicant Contact Byoungjun Park
Correspondent
Empirical Testing Corp
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 03/15/2018
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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