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FDA 510(k)

Vantage Lumbar Decompression Kit

K-Number: K263208 · 2026-10-14

ApplicantSurGenTec, LLC
Decision Date2026-10-14
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vantage Lumbar Decompression Kit is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2026-10-14 under 510(k) number K263208. 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 Vantage Lumbar Decompression Kit?

Vantage Lumbar Decompression Kit is a medical device that received FDA 510(k) clearance on 2026-10-14. The listed applicant is SurGenTec, LLC. The 510(k) number is K263208.

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

Vantage Lumbar Decompression Kit received FDA 510(k) clearance on 2026-10-14, under 510(k) number K263208.

Who is the listed applicant for Vantage Lumbar Decompression Kit?

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

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

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

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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.

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Official Source

View on FDA Database →

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

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