Ht Medical D.B.A. Xenix Medical 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
RIVA Posterior Fixation System; RIVA Posterior Fixation System Navigation Instruments510(k)Jun 12, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 12, 2025
neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical510(k)Sep 1, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 1, 2023
Xenix Medical Sacroiliac Fixation System510(k)Aug 15, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 15, 2023