Osseus Fusion Systems FDA Approvals

0 new drug approvals and 3 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
Pisces-SA STANDALONE ALIF Interbody System510(k)Feb 10, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Feb 10, 2023
Black Diamond POCT Spinal System510(k)Nov 3, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 3, 2022
PISCES-SA Standalone ALIF Interbody System510(k)May 6, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 6, 2022