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510(k) K152568

Device
C-VBR
Applicant
CARDINAL SPINE, LLC
510(k) number
K152568
Product code
PLR  
Decision
Substantially Equivalent (SESE)
Decision date
2016-02-11
Date received
2015-09-09
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
No

Applicant Contact#

Contact
NATASHA LONNON
Address
12307 Old La Grange Rd. Suite 105 Louisville KY US 40245 40245

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PLR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.2025-11-10
K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLC2023-10-13
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

Legacy Summary#

summary

FDA Review#

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