FDA.reportPublic FDA data

510(k) K260480

Device
VELYS™ Robotic-Assisted Solution
Applicant
Depuy Ireland UC
510(k) number
K260480
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2026-06-25
Date received
2026-02-13
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Camille Chua
Address
Loughbeg Ringaskiddy, Co. Cork IE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OLO#

510(k), Device, Applicant table
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K261205SPINEART Navigation Instrument SystemSpineart SA2026-07-29
K261024TMINI Miniature Robotic SystemTHINK Surgical, Inc.2026-07-24
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K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics2026-07-22
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K253921VERTICALE® Navigation InstrumentsSilony Medical GmbH2026-06-26
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