FDA 510(k) Applications for Medical Device Product Code "PLR"

FDA 510(k) Number Applicant Device Name Decision Date
K172032 Aesculap Implants Systems, Inc. Modulift Vertebral Body Replacement (VBR) System 11/20/2017
K190426 Astura Medical, LLC ALTA Anterior Cervical Corpectomy System 10/24/2019
K192145 Bright Spine Galileo Vertebral Body Replacement Device 04/21/2020
K221542 Bright Spine Galileo Vertebral Body Replacement Device 01/13/2023
K152568 CARDINAL SPINE, LLC C-VBR 02/11/2016
K212126 CMF Medicon Surgical Inc. MediExpand Cervical Expandable VBR System 04/04/2022
K173893 coLigne, AG Trabis 09/06/2018
K211320 K2M, Inc. CAPRI Corpectomy Cage System 02/24/2022
K190284 Medos International SARL Bengal Stackable Cage System 12/20/2019
K193412 Nexxt Spine LLC NEXXT MATRIXX System 02/24/2020
K180550 NuVasive, Incorporated NuVasive Monolith Cervical Corpectomy System 11/20/2018
K151651 NUVASIVE, INCORPORATED NuVasive X-CORE Mini Cervical Expandable VBR System 09/25/2015
K191778 Omnia Medical, LLC Omnia Medical VBR 08/28/2019
K183071 Stryker Spine VLIFT-s Vertebral Body Replacement System 01/10/2019
K180673 Zavation Medical Products LLC Normandy VBR System 07/13/2018
K191423 Zavation Medical Products LLC Normandy VBR System 08/06/2019


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