FDA.report

510(k) K232481

Device
RIGEL™ 3DR Anterior Cervical Corpectomy System
Applicant
MiRus, LLC
510(k) number
K232481
Product code
PLR
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-13
Date received
2023-08-16
Regulation
888.3060
Classification name
Spinal Vertebral Body Replacement Device - Cervical
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jordan Bauman
Address
1755 W. Oak Pkwy. Suite 100 Marietta GA US 30062 30062

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code PLR

510(k)DeviceApplicantDecision date
K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.2025-11-10
K221542Galileo Vertebral Body Replacement DeviceBright Spine2023-01-13
K212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.2022-04-04
K211320CAPRI Corpectomy Cage SystemK2m, Inc.2022-02-24
K192145Galileo Vertebral Body Replacement DeviceBright Spine2020-04-21
K193412NEXXT MATRIXX SystemNexxt Spine, LLC2020-02-24
K190284Bengal Stackable Cage SystemMedos International SARL2019-12-20
K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC2019-10-24
K191778Omnia Medical VBROmnia Medical, LLC2019-08-28
K191423Normandy VBR SystemZavation Medical Products, LLC2019-08-06
K183071VLIFT-s Vertebral Body Replacement SystemStryker Spine2019-01-10
K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated2018-11-20
K173893TrabisColigne AG2018-09-06
K180673Normandy VBR SystemZavation Medical Products, LLC2018-07-13
K172032Modulift Vertebral Body Replacement (VBR) SystemAesculap Implants Systems, Inc.2017-11-20