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Spinal Frontiers · Regulatory Watch · FDA decision

SurGenTec clears a lumbar decompression kit

FDA decision · SurGenTec

14 October 2026

A kit for lumbar decompression was cleared under the arthroscope category, with manual rongeurs as a secondary product code. The FDA record does not give its indications.

Type
FDA decision
Company
SurGenTec
Device
Vantage Lumbar Decompression Kit
Date
14 October 2026
Jurisdiction
US
Classification
510(k) K263208 (HRX; HAE)
Source
FDA 510(k) database

Official source →Source checked

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