Cutting Edge Spine, LLC 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
EVOL® ha Hyper C Cervical Interbody Fusion System510(k)Mar 12, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 12, 2025
T-FIX 3DSI Joint Fusion System510(k)Apr 5, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Apr 5, 2023
T-FIX® 3DSI Joint Fusion System510(k)Jun 24, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 24, 2022