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FDA 510(k)

VantageTM Lumbar Decompression Kit

K-Number: K252546 · 2026-03-12

ApplicantAllevion Medical, LLC
Decision Date2026-03-12
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VantageTM Lumbar Decompression Kit is the device name listed in this FDA 510(k) record. The listed applicant is Allevion Medical, LLC. It received FDA 510(k) clearance on 2026-03-12 under 510(k) number K252546. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VantageTM Lumbar Decompression Kit?

VantageTM Lumbar Decompression Kit is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Allevion Medical, LLC. The 510(k) number is K252546.

When did VantageTM Lumbar Decompression Kit receive FDA 510(k) clearance?

VantageTM Lumbar Decompression Kit received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252546.

Who is the listed applicant for VantageTM Lumbar Decompression Kit?

The FDA 510(k) record lists Allevion Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VantageTM Lumbar Decompression Kit?

The FDA product code for VantageTM Lumbar Decompression Kit is HRX.

Related Devices (Code: HRX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLCK253523Freedom DS™ Decompression SystemSpinal SimplicityK253217MiiS 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)K250795PUREVUE™ FMSW.O.M. World of Medicine GmbHK252666Articulator Arthroscopic BurJoint Preservation Innovations, LLCK252458Kyphoplasty Balloon Dilatation CathetersShanghai Lange Medtech Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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