FDA.reportPublic FDA data

510(k) K233256

Device
Robotic Integration Instruments
Applicant
DePuy Synthes
510(k) number
K233256
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2024-06-17
Date received
2023-09-28
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
Nicole Aeschbacher
Address
Eimattstrasse 3 Oberdor CH 4436 4436

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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K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.2026-03-03
K260222Mako Total Knee ApplicationMako Surgical Corp.2026-02-25
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K254148VERTICALE GPS InstrumentsSilony Medical GmbH2026-02-19