Biocore9, LLC FDA Approvals

0 new drug approvals and 2 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Biocore9 Acetabular Cup System510(k)May 17, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 17, 2022
Biocore9 Femoral Head Resurfacing Component510(k)Jan 19, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 19, 2021