Spectrum Spine, Inc. 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
Expandable Titanium PLIF/TLIF System510(k)Oct 24, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Oct 24, 2025
Spectrum Spine Lumbar Cage System510(k)Apr 4, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Apr 4, 2025
Spectrum Spine Cervical Cage System510(k)May 30, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 30, 2024