Orthopedic Stereotaxic Instrument

Curexo, Inc.

The following data is part of a premarket notification filed by Curexo, Inc. with the FDA for Cuvis-spine.

Pre-market Notification Details

Device IDK201569
510k NumberK201569
Device Name:CUVIS-spine
ClassificationOrthopedic Stereotaxic Instrument
Applicant Curexo, Inc. 577, Gangnam-Daero, Seocho-Gu Seoul,  KR 06530
ContactJungeun Park
CorrespondentDo Hyun Kim
BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul,  KR 06210
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-11
Decision Date2021-05-19

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