FDA 510(k) Applications Submitted by Chiara Cunico
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K220652 |
03/07/2022 |
Knee 3 |
Brainlab AG |
| K210989 |
04/02/2021 |
Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System |
Brainlab AG |
| K201276 |
05/13/2020 |
ExacTrac Dynamic |
Brainlab AG |
| K211544 |
05/19/2021 |
Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization |
Brainlab AG |
| K221618 |
06/03/2022 |
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System |
Brainlab AG |
| K211939 |
06/23/2021 |
ExacTrac Dynamic |
Brainlab AG |
| K201752 |
06/26/2020 |
Disposable Pre-calibrated Suction |
Brainlab AG |
| K212245 |
07/19/2021 |
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning S |
Brainlab AG |
| K202050 |
07/24/2020 |
Cranial 4Pi Immobilization |
Brainlab AG |
| K212420 |
08/04/2021 |
Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio |
Brainlab AG |
| K192703 |
09/27/2019 |
Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update |
Brainlab AG |
| K203173 |
10/26/2020 |
ExacTrac Dynamic |
Brainlab AG |
| K213930 |
12/16/2021 |
Brainlab Elements Guide XT, Guide 3.0 |
Brainlab AG |
| K203679 |
12/17/2020 |
Automatic Registration |
Brainlab AG |
| K203681 |
12/17/2020 |
RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review |
Brainlab AG |
| K213989 |
12/20/2021 |
Cranial EM System |
Brainlab AG |
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