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 is a medical device manufacturer specializing in orthopedic surgical solutions. The company operates with a manufacturing facility in Boca Raton, US.

SurGenTec has received 23 FDA 510(k) clearances from 23 total submissions since its first clearance in 2017. Orthopedic devices represent 78% of the company's regulatory portfolio. The company remains actively engaged in FDA 510(k) submissions, with its most recent clearance in 2026.

SurGenTec's product portfolio includes fusion systems, graft delivery instruments, bone void fillers, and specialized surgical navigation tools. Recent cleared devices span joint fusion platforms, graft delivery systems, and hydroxyapatite-based bone regeneration products.

Explore SurGenTec's complete device portfolio, product codes, and FDA 510(k) clearance dates in the database.

FDA 510(k) Regulatory Record - SurGenTec, LLC

23 devices

1-12 of 23