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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 K191655
Device Name MEGAFIX® Pedicle Screw Spinal System
Applicant
SeohanCare Co., Ltd
2F Da-dong 22, Gimpo-daero 2918beon-gil, Wolgot-myeon
Gimpo-si,  KR 10020
Applicant Contact Chae Lynn Song
Correspondent
Empirical Testing Corp.
4628 Northpark Drive
Colorado Springs,  CO  80918
Correspondent Contact Meredith May
Regulation Number888.3070
Classification Product Code
NKB  
Date Received06/21/2019
Decision Date 03/06/2020
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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