OsteoCentric Technologies FDA Approvals

0 new drug approvals and 11 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
OsteoCentric® UnifiMI® TCS Plating System510(k)Aug 16, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 16, 2025
The OsteoCentric Bone Plate and Screw System510(k)Mar 18, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 18, 2025
OsteoCentric Technologies Cannulated Fasteners and Nuts510(k)Oct 9, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 9, 2024
OsteoCentric Dental Implant System510(k)Oct 5, 2023Dental	Dental	510(k)Substantially Equivalent (Traditional)	Oct 5, 2023
Integrity-SI® Fusion System510(k)Sep 21, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 21, 2023
OsteoCentric ACL Fixation System510(k)Jun 29, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 29, 2023
OsteoCentric Integrated Hip Fastener System510(k)Apr 18, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 18, 2023
Integrity-SI Fusion System510(k)Sep 12, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 12, 2022
OsteoCentric Spine MIS Pedicle Fastener System510(k)Jul 28, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 28, 2022
Cannulated Fasteners and Nuts510(k)Aug 3, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 3, 2021
Cannulated Fasteners and Nuts510(k)Apr 14, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 14, 2021