Vantage Lumbar Decompression Kit— 510(k) K263208

Name: FDA 510(k) clearance K263208
Creator: U.S. Food and Drug Administration
Published: 2026-10-14

Substantially Equivalent

SurGenTec, LLC

FDA 510(k) clearance K263208 for Vantage Lumbar Decompression Kit, Substantially Equivalent on 2026-10-14. Applicant: SurGenTec, LLC. Device class: 2.

Clearance details

Applicant: SurGenTec, LLC
Product code: Product code HRX
Device class: Class 2
Regulation: 21 CFR 888.1100
Advisory panel: Orthopedic
Date received: 2026-09-14
Decision date: 2026-10-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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K262121 — Ion-L Navigated Instruments2026-07-24
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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.