FDA.report

510(k) K232173

Device
Ascend VBR System, Ascend NanoTec VBR System
Applicant
Alphatec Spine, Inc.
510(k) number
K232173
Product code
MQP
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-06
Date received
2023-07-21
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
Sandy Gill
Address
1950 Camino Vida Roble Carlsbad CA US 92008 92008

FDA Registration Numbers

Source Documents

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

Related GUDID Devices

Primary DIBrandCompanyPublished
00190376658568AscendALPHATEC SPINE, INC.2025-04-03
00190376658513AscendALPHATEC SPINE, INC.2025-04-03
00190376658681AscendALPHATEC SPINE, INC.2025-04-03
00190376658636AscendALPHATEC SPINE, INC.2025-04-03
00190376658643AscendALPHATEC SPINE, INC.2025-04-03
00190376658551AscendALPHATEC SPINE, INC.2025-04-03
00190376658599AscendALPHATEC SPINE, INC.2025-04-03
00190376658704AscendALPHATEC SPINE, INC.2025-04-03
00190376658711AscendALPHATEC SPINE, INC.2025-04-03
00190376658612AscendALPHATEC SPINE, INC.2025-04-03
00190376658537AscendALPHATEC SPINE, INC.2025-04-03
00190376658780AscendALPHATEC SPINE, INC.2025-04-03
00190376658797AscendALPHATEC SPINE, INC.2025-04-03
00190376658698AscendALPHATEC SPINE, INC.2025-04-03
00190376658742AscendALPHATEC SPINE, INC.2025-04-03
00190376658520AscendALPHATEC SPINE, INC.2025-04-03
00190376658803AscendALPHATEC SPINE, INC.2025-04-03
00190376658766AscendALPHATEC SPINE, INC.2025-04-03
00190376658667AscendALPHATEC SPINE, INC.2025-04-03
00190376658605AscendALPHATEC SPINE, INC.2025-04-03
00190376658728AscendALPHATEC SPINE, INC.2025-04-03
00190376658674AscendALPHATEC SPINE, INC.2025-04-03
00190376632711AscendALPHATEC SPINE, INC.2025-04-03
00190376658759AscendALPHATEC SPINE, INC.2025-04-03
00190376658544AscendALPHATEC SPINE, INC.2025-04-03
00190376658575AscendALPHATEC SPINE, INC.2025-04-03
00190376658629AscendALPHATEC SPINE, INC.2025-04-03
00190376658582AscendALPHATEC SPINE, INC.2025-04-03
00190376658773AscendALPHATEC SPINE, INC.2025-04-03
00190376658735AscendALPHATEC SPINE, INC.2025-04-03

Other 510(k) Records For Product Code MQP

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
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