Techfit Digital Surgery, Inc. FDA Approvals

0 new drug approvals and 4 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
TECHFIT Patient-Specific Cranial System510(k)Oct 27, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Oct 27, 2025
TECHFIT DISRP® System510(k)Dec 11, 2024Dental	Dental	510(k)Substantially Equivalent (Traditional)	Dec 11, 2024
TECHFIT Diagnostic Models510(k)Jan 6, 2023Radiology	Radiology	510(k)Substantially Equivalent (Traditional)	Jan 6, 2023
AFFINITY Proximal Tibia System510(k)Mar 21, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 21, 2022