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510(k) K222698

Device
CUVIS-spine
Applicant
Curexo, Inc.
510(k) number
K222698
Product code
OLO  
Decision
Substantially Equivalent (SESE)
Decision date
2022-10-07
Date received
2022-09-07
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Orthopedic
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jungeun Park
Address
577, Gangnam-Daero, Seocho-Gu Seoul KR 06530 06530

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261852OTS HipOrtoma AB2026-07-01
K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH2026-06-26
K260480VELYS™ Robotic-Assisted SolutionDepuy Ireland UC2026-06-25
K260369Dynamis Robotic Surgical SystemLEM Surgical AG2026-06-20
K261665CORUS™ Navigation System-GNProvidence Medical Technology, Inc.2026-06-18
K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.2026-06-02
K261060Navigated LLIF Impactable TrackerTyber Medical, LLC2026-05-29
K254157CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyMedos International SARL2026-05-26
K260329Ion-C Navigation InstrumentsSurGenTec, LLC2026-05-22
K260582ROSA® Shoulder SystemOrthosoft Inc. (d/b/a) Zimmer CAS2026-05-21
K252880Pytheas Your Guided TrajectoryPytheas Navigation Sas2026-05-11
K260011Foundation Surgical Navigated Lateral Disc Prep InstrumentsFoundation Surgical Group, Inc.2026-04-16
K254158SPINEART Navigation Instrument SystemSpineart SA2026-04-09
K260240SYMPHONY Navigation Ready InstrumentsMedos International SARL2026-03-27
K260601REAL INTELLIGENCE™ CORI™Blue Belt Technologies, Inc.2026-03-26

Legacy Summary#

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FDA Review#

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