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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 16 Results
ProductCode: OLO Applicant: BRAINLAB AG Decision Date To: 05/31/2023
 
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cirq arm system (2.0);alignment system spine Brainlab AG K222966 10/27/2022
spine & trauma navigation, spine navigation, navigation software spine & trauma, alignment system spine, alignment software spine, cirq arm system Brainlab AG K221618 08/30/2022
knee 3 Brainlab AG K220652 06/03/2022
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 spine, elements spine screw planning Brainlab AG K212245 04/13/2022
automatic registration Brainlab AG K203679 03/18/2021
cirq robotic alignment module, cirq, cirq robotic alignment module spinal, cirq robotic alignment cranial and spine, cirq robotic alignment cranial and spine system Brainlab AG K202320 12/23/2020
hip7 Brainlab AG K193307 06/02/2020
spine & trauma navigation Brainlab AG K183605 08/29/2019
spine & trauma navigation Brainlab AG K191285 06/11/2019
navigation software hip-universal; navigation software hip thr-aesculap BRAINLAB AG K122011 11/15/2012
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