FDA.report

510(k) K233359

Device
DOMINION Expandable Corpectomy System
Applicant
Astura Medical
510(k) number
K233359
Product code
MQP
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-08
Date received
2023-09-29
Regulation
888.3060
Classification name
Spinal Vertebral Body Replacement Device
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
Parker Kelch
Address
4949 W. Royal Ln. Irving TX US 75063 75063

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code MQP

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K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG2024-04-04
K231134VerteLoc Spinal SystemSignature Orthopaedics Pty, Ltd.2024-02-13
K232173Ascend VBR System, Ascend NanoTec VBR SystemAlphatec Spine, Inc.2023-10-06
K211892ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)Arftx Medical, LLC2022-10-06
K202637F3D Corpectomy SystemCorelink, LLC2020-12-23
K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG2020-05-29
K193506NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR SystemNu Vasive, Incorporated2020-02-26
K192117Small VBR™Ulrich GmbH & Co. KG2019-11-01
K190349MediExpand TL Expandable VBR SystemCmf Medicon Surgical, Inc.2019-10-24
K192214CarboClear VBR SystemCarboFix Orthopedics , Ltd.2019-10-11
K183054SYNMESH SystemDepuy Synthes Spine2019-05-23
K190147COLOSSEUM MeshGlobus Medical, Inc.2019-05-08
K183197PYRAMESH™ Implant SystemMedtronic Sofamor Danek USA, Inc.2019-04-04