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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthopedic Stereotaxic Instrument
510(k) Number K201569
Device Name CUVIS-spine
Applicant
Curexo, Inc.
577, Gangnam-Daero, Seocho-Gu
Seoul,  KR 06530
Applicant Contact Jungeun Park
Correspondent
Bt Solutions, Inc.
Unit 904, Eonju-Ro 86-Gil 5, Gangnam-Gu
Seoul,  KR 06210
Correspondent Contact Do Hyun Kim
Regulation Number882.4560
Classification Product Code
OLO  
Date Received06/11/2020
Decision Date 05/19/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
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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