Medical Device Manufacturer · US , Irvine , CA

Biogennix, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2010

Recent clearances: Morpheus® Moldable, Agilon Strip, Agilon Moldable

8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Biogennix, LLC Orthopedic ✕

8 devices
1-8 of 8
Cleared Apr 30, 2024
Morpheus® Moldable
K240621 · MQV
Orthopedic · 56d
Cleared Mar 30, 2020
Agilon Strip
K193487 · MQV
Orthopedic · 104d
Cleared Feb 13, 2020
Agilon Moldable
K193168 · MQV
Orthopedic · 90d
Cleared Aug 09, 2019
Morpheus-C
K190371 · MQV
Orthopedic · 175d
Cleared Sep 18, 2018
Sypher Spacer System
K181337 · MAX
Orthopedic · 120d
Cleared Feb 19, 2015
SYPHER SPACER SYSTEM
K141798 · OVD
Orthopedic · 231d
Cleared May 20, 2014
OSTEOSPAN MORPHEUS
K132377 · MQV
Orthopedic · 293d
Cleared Jul 29, 2010
BIOGENNIX RPC
K093342 · MQV
Orthopedic · 276d
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