Medical Device Manufacturer · US , Irvine , CA

Biogennix, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2010

8

Total

8

Cleared

0

Denied

FDA 510(k) cleared devices by Biogennix, LLC Orthopedic ✕

8 devices

1-8 of 8

Cleared Apr 30, 2024

Morpheus® Moldable

Orthopedic · 56d

Cleared Mar 30, 2020

Orthopedic · 104d

Cleared Feb 13, 2020

Agilon Moldable

Orthopedic · 90d

Cleared Aug 09, 2019

Orthopedic · 175d

Cleared Sep 18, 2018

Sypher Spacer System

Orthopedic · 120d

Cleared Feb 19, 2015

SYPHER SPACER SYSTEM

Orthopedic · 231d

Cleared May 20, 2014

OSTEOSPAN MORPHEUS

Orthopedic · 293d

Cleared Jul 29, 2010

Orthopedic · 276d