Medical Device Manufacturer · US , Boca Raton , FL

SurGenTec, LLC - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 2017

Total

Cleared

Denied

SurGenTec, LLC has 23 FDA 510(k) cleared orthopedic devices. Based in Boca Raton, US.

Latest FDA clearance: Mar 2026. Active since 2017.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by SurGenTec, LLC

23 devices

1-12 of 23

Cleared Mar 20, 2026

TiLink-L Navigation Instruments

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

K243945 · KNW

General & Plastic Surgery · 125d

Cleared Feb 05, 2025

GraftGun Universal Graft Delivery System (GDS)

K243580 · FMF

Orthopedic · 78d

Cleared Dec 27, 2024

TiLink-P SI Joint Fusion System

TiLink-P Joint Fusion System

K242414 · OUR

Orthopedic · 99d

Cleared Aug 21, 2024

TiLink-P SI Joint Fusion System

K242141 · OUR

Orthopedic · 30d

Cleared Aug 09, 2024

ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit)

K240664 · KNW

General & Plastic Surgery · 154d

SurGenTec, LLC - FDA 510(k) Cleared Devices

FDA 510(k) cleared devices by SurGenTec, LLC

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