Wenzel Spine, 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
VariLift-C Cervical Interbody Fusion System510(k)Aug 26, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 26, 2026
panaSIa SI Fusion System510(k)Jul 9, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 9, 2025
VariLift®-C Interbody Fusion System510(k)Sep 27, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 27, 2023
primaLOK SP Interspinous Fusion System510(k)Aug 15, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 15, 2023