Atlas FDA

PLR

19 FDA 510(k) clearances · Product code

155 daysmedian time to decision
312 days90th percentile
19clearances measured

FDA profile

Official device name
Spinal Vertebral Body Replacement Device - Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Vertebral body replacement in the cervical spine.
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RecordFirmDate
Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy Implant (K252822)Atlas Spine, Inc.2026-07-15
Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (K252560)Atlas Spine, Inc.2025-11-10
RIGEL™ 3DR Anterior Cervical Corpectomy System (K232481)MiRus, LLC2023-10-13
Galileo Vertebral Body Replacement Device (K221542)Bright Spine2023-01-13
MediExpand Cervical Expandable VBR System (K212126)Cmf Medicon Surgical, Inc.2022-04-04
CAPRI Corpectomy Cage System (K211320)K2m, Inc.2022-02-24
Galileo Vertebral Body Replacement Device (K192145)Bright Spine2020-04-21
NEXXT MATRIXX System (K193412)Nexxt Spine, LLC2020-02-24
Bengal Stackable Cage System (K190284)Medos International SARL2019-12-20
ALTA Anterior Cervical Corpectomy System (K190426)Astura Medical, LLC2019-10-24
Omnia Medical VBR (K191778)Omnia Medical, LLC2019-08-28
Normandy VBR System (K191423)Zavation Medical Products, LLC2019-08-06
VLIFT-s Vertebral Body Replacement System (K183071)Stryker Spine2019-01-10
NuVasive Monolith Cervical Corpectomy System (K180550)Nu Vasive, Incorporated2018-11-20
Trabis (K173893)Coligne AG2018-09-06
Normandy VBR System (K180673)Zavation Medical Products, LLC2018-07-13
Modulift Vertebral Body Replacement (VBR) System (K172032)Aesculap Implants Systems, Inc.2017-11-20
C-VBR (K152568)Cardinal Spine, LLC2016-02-11
NuVasive X-CORE Mini Cervical Expandable VBR System (K151651)Nu Vasive, Incorporated2015-09-25

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Every clearance here is in the API, with alerts when new ones post.