Restor3D FDA Approvals

0 new drug approvals and 12 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
Veritas Shoulder System510(k)Jul 1, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 1, 2026
Veritas Reverse Total Shoulder System510(k)May 7, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 7, 2026
Kinos Total Ankle System510(k)Sep 3, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Sep 3, 2025
restor3d Reverse Total Shoulder Arthroplasty System510(k)May 19, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 19, 2025
Kinos Total Ankle System510(k)Oct 18, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 18, 2024
Kinos Total Ankle System510(k)Jul 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 22, 2024
restor3d TIDAL Lumbar Interbody Fusion System510(k)Jan 22, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Jan 22, 2024
Kinos Axiom Total Ankle System510(k)Nov 28, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Nov 28, 2023
Extremity Staple510(k)Aug 3, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 3, 2023
Axiom PSR System510(k)Mar 30, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 30, 2023
restor3d TiDAL Lumbar Interbody Fusion Device510(k)Jun 17, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 17, 2022
restor3d Pin Implants510(k)Jan 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 4, 2022