Biogennix, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K240621Morpheus® Moldable; Agilon® MoldableApril 30, 2024
K193487Agilon StripMarch 30, 2020
K193168Agilon MoldableFebruary 13, 2020
K190371Morpheus-CAugust 9, 2019
K181337Sypher Spacer SystemSeptember 18, 2018
K141798SYPHER SPACER SYSTEMFebruary 19, 2015
K142828osteoSPAN MorpheusJanuary 15, 2015
K132377OSTEOSPAN MORPHEUSMay 20, 2014
K093342BIOGENNIX RPCJuly 29, 2010