Restor3D, Inc. FDA Approvals

0 new drug approvals and 6 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
Velora Acetabular System510(k)Dec 5, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Dec 5, 2025
iTotal® Identity Cruciate Retaining 3DP Porous Knee Replacement System510(k)Mar 27, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 27, 2025
TIDAL Fusion Cage System510(k)Mar 24, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 24, 2025
restor3d Kinos Axiom Total Ankle System510(k)Apr 29, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 29, 2024
restor3d MTP Implant510(k)May 25, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 25, 2022
Restor3d Utility Wedge510(k)Jun 17, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 17, 2021