FDA.reportPublic FDA data

510(k) K183197

Device
PYRAMESH™ Implant System
Applicant
Medtronic Sofamor Danek USA, INC.
510(k) number
K183197
Product code
MQP  
Decision
Substantially Equivalent (SESE)
Decision date
2019-04-04
Date received
2018-11-19
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
No

Applicant Contact#

Contact
ANkit K. Shah
Address
1800 Pyramid Pl. Memphis TN US 38132 38132

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MQP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253158VyBrate™ VBR SystemVy Spine, LLC2026-01-07
K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc.2024-11-07
K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG2024-04-04
K233359DOMINION Expandable Corpectomy SystemAstura Medical2024-03-08
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