FDA.reportPublic FDA data

510(k) K252562

Device
Spine & Trauma Navigation Instruments
Applicant
Brainlab AG
510(k) number
K252562
Product code
OLO
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-12
Date received
2025-08-14
Regulation
882.4560
Classification name
Orthopedic Stereotaxic Instrument
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Esther Moreno Garcia
Address
Olof-Palme-Str 9 Munich DE 81829 81829

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
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
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