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Spinal Frontiers · Regulatory Watch · FDA decision

SurGenTec clears lateral SI joint fusion system

FDA decision · SurGenTec

24 August 2026

SurGenTec's TiLink-L sacroiliac joint fusion system was cleared, with navigation listed as a secondary product code.

Type: FDA decision
Company: SurGenTec
Device: TiLink-L SI Joint Fusion System
Date: 24 August 2026
Jurisdiction: US
Classification: 510(k) K261381 (OUR; OLO)
Source: FDA 510(k) database

Official source →Source checked

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