SurGenTec, LLC - FDA 510(k) Cleared Devices

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 24 FDA 510(k) clearances from 24 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.

Regulatory submissions have been managed by Quality Solutions and Support and Quality Solutions and Support, LLC.