FDA 510(k)

VantageTM Lumbar Decompression Kit

K-Number: K252546 · 2026-03-12

Decision Date2026-03-12

Product CodeHRX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VantageTM Lumbar Decompression Kit is a medical device manufactured by Allevion Medical, LLC. It received FDA 510(k) clearance on 2026-03-12 under approval 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. It is manufactured by Allevion Medical, LLC. The 510(k) number is K252546.

When was VantageTM Lumbar Decompression Kit approved by the FDA?

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

What company makes VantageTM Lumbar Decompression Kit?

VantageTM Lumbar Decompression Kit is manufactured by Allevion Medical, LLC.

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

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

Related Clinical Trials

NCT03072927 MILD® Percutaneous Image-Guided Lumbar Decompression: A Medicare Claims Study RECRUITING

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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.