VantageTM Lumbar Decompression Kit— 510(k) K252546

Name: FDA 510(k) clearance K252546
Creator: U.S. Food and Drug Administration
Published: 2026-03-12

Substantially Equivalent

Allevion Medical, LLC

FDA 510(k) clearance K252546 for VantageTM Lumbar Decompression Kit, Substantially Equivalent on 2026-03-12. Applicant: Allevion Medical, LLC. Device class: 2.

Summary

Allevion Medical's VantageTM Lumbar Decompression Kit is filed under HRX, arthroscopes. The record doesn't list what the kit contains.

Class II, 21 CFR 888.1100. Orthopedic is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Allevion Medical filed from Boca Raton, Florida. Review took 212 calendar days (August 12, 2025 to March 12, 2026).

Clearance details

Applicant: Allevion Medical, LLC
Product code: Product code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2025-08-12
Decision date: 2026-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HRX

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K263208 — Vantage Lumbar Decompression Kit2026-10-14
K260156 — TruVision Single-Use 1.9mm Arthroscopy System2026-10-09
K260203 — Fule Vertebroplasty Balloon Catheter2026-08-28
K254103 — HOPKINS Telescopes for Arthroscopy2026-08-26
K252790 — Digital ClarusScope System and Digital NeuroPEN System2026-05-26

Adverse events under product code HRX

product code HRX

Injury: 623
Malfunction: 11,257
Total: 11,880

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.