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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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