Spine Wave, Inc. FDA Approvals

0 new drug approvals and 8 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
Dynamo Spinal Cement; Salvo® Spine System510(k)Jun 15, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 15, 2026
Exceed® Biplanar Expandable Interbody System510(k)May 29, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 29, 2026
Testa TP Pivoting Spacer System510(k)Jun 27, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 27, 2025
Annex® 2 Adjacent Level System510(k)Jun 6, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jun 6, 2025
Salvo® Robotic Navigation Instruments510(k)Apr 3, 2025Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Apr 3, 2025
Salvo® Spine System510(k)May 6, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	May 6, 2024
Exceed Biplanar Expandable Interbody System510(k)Jul 25, 2023Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jul 25, 2023
Salvo® Spine System510(k)Aug 29, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Aug 29, 2022