Ortho-Design (Pty), Ltd. 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
VersaTap Suture Anchor (ADP050); VersaPEEK Suture Anchor (APP002); MicroTi Suture Anchor (ATP003-M); VersaLat Ti Suture Anchor (ADP021-TI); VersaLat Suture Anchor (ADP021-PK)510(k)Aug 29, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 29, 2024
VersaTap, VersaLat, DueLock, VersaTi, MiniTi510(k)Dec 6, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 6, 2021