CUVIS-spine

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 IDK222698
510k NumberK222698
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 68-gil 5, Gangnam-gu Seoul,  KR 06210
Product CodeOLO  
CFR Regulation Number882.4560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-09-07
Decision Date2022-10-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800043830013 K222698 000

Trademark Results [CUVIS-spine]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CUVIS-SPINE
CUVIS-SPINE
79358787 not registered Live/Pending
CUREXO Inc.
2022-11-07

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