FDA.report

510(k) K252546

Device
VantageTM Lumbar Decompression Kit
Applicant
Allevion Medical, LLC
510(k) number
K252546
Product code
HRX
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-12
Date received
2025-08-12
Regulation
888.1100
Classification name
Arthroscope
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
Stephen Inglese
Address
915 Clint Moore Rd. Boca Raton FL US 33487 33487

FDA Registration Numbers

Source Documents

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

Other 510(k) Records For Product Code HRX

510(k)DeviceApplicantDecision date
K253523Freedom DS™ Decompression SystemSpinal Simplicity2026-04-16
K253217MiiS Horus Arthroscope (EJA 100); MiiS Horus Endoscope Display System -Tablet (EDS 500); MiiS Horus Endoscope Display System -Video Box (EVS 700)Medimaging Integrated Solution, Inc (Miis)2025-12-23
K250795PUREVUE™ FMSW.O.M. World of Medicine GmbH2025-12-05
K252666Articulator Arthroscopic BurJoint Preservation Innovations, LLC2025-11-21
K252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.2025-11-03
K252020TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade AssemblyHand Biomechanics Lab, Inc.2025-10-15
K252594UltraGuideCTR® image guided soft tissue release systemSonex Health2025-09-29
K243774ELID (Endoscopic Less Invasive Decompression) SystemLesspine Innovations2025-08-27
K241990SpineSite Endoscope SystemHydrocision, Inc.2025-07-30
K243602Arthrex Spine EndoscopeArthrex, Inc.2025-05-16
K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC2024-12-11
K243020MIDASVuIntravu, Inc.2024-12-02
K233800Vertos mild Device Kit (MDK-0002)Vertos Medical, Inc.2024-05-06
K240535Digital ClarusScope System; Digital NeuroPEN SystemClarus Medical, LLC2024-04-25
K233675FMS VUE™ Fluid Management and Tissue Debridement SystemDePuy Mitek, Inc.2024-02-26