FDA 510(k) Applications Submitted by Esther Moreno Garcia

FDA 510(k) Number Submission Date Device Name Applicant
K240701 03/14/2024 Drill Guide; Drill Bit; Spine & Trauma Navigation Brainlab AG
K242569 08/28/2024 Mixed Reality Spine Navigation Brainlab AG
K223288 10/25/2022 Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI Brainlab AG
K243698 11/29/2024 Alignment System Cranial, with Alignment Software Cranial with LITT; Cirq Alignment Software Cranial Biopsy; Cirq Alignment Software Cranial sEEG; VarioGuide Alignment Software Cranial; Cirq Alignment Software Cranial LITT Brainlab AG
K223734 12/13/2022 ENT EM Brainlab AG
K234047 12/21/2023 Automatic Registration Brainlab AG
K223864 12/23/2022 Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial Brainlab AG


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