Xelite Biomed , Ltd. 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
XeliteMed SuperM-Fix Spinal Bone Cement510(k)Jan 28, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 28, 2026
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System510(k)Apr 11, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 11, 2025
XeliteMed VertehighFix High Viscosity Spinal Bone Cement510(k)Sep 18, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 18, 2024