FDA.reportPublic FDA data

510(k) K230243

Device
ROSA® Knee System
Applicant
Orthosoft D/B/A Zimmer Cas
510(k) number
K230243
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-29
Date received
2023-01-30
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
No

Applicant Contact#

Contact
Aura Helena Corredor
Address
75 Queen St. Suite 3300 Montreal CA H3C 2N6 H3C 2N6

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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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