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.

Clearance details

Applicant: Allevion Medical, LLC
Product code: 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 ↗

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K253217 — MiiS Horus Arthroscope (EJA 100) +2 more2025-12-23

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.