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510(k) K202320

Device
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial And Spine System
Applicant
Brainlab AG
510(k) number
K202320
Product code
OLO  
Decision
Substantially Equivalent (SESE)
Decision date
2020-12-23
Date received
2020-08-17
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Cunico Chiara
Address
Olof-Palme-Str. 9 Munich DE 80809 80809

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
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
K252037CUVIS-joint (CJ150)Curexo, Inc.2026-03-25
K253604TiLink-L Navigation InstrumentsSurGenTec, LLC2026-03-20
K253444EUROPA™ Posterior Cervical Fusion Navigated InstrumentsMiRus, LLC2026-03-18
K260546Q Pedicle InstrumentsK2m, Inc.2026-03-17
K260010TMINI® Miniature Robotic SystemTHINK Surgical, Inc.2026-03-03
K260222Mako Total Knee ApplicationMako Surgical Corp.2026-02-25

Legacy Summary#

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FDA Review#

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