Ortho Solutions UK , Ltd. 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
Succession AFN System510(k)Aug 7, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 7, 2025
COGNiTiON Staple System510(k)Feb 23, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Feb 23, 2024
Volition Plating System510(k)Apr 13, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 13, 2021