Meditech Spine Receives FDA Clearance for Talos Lumbar PEEK Devices

By Julie A. Vetalice

Meditech Spine received FDA 510(k) clearance for Talos® Lumbar PEEK interbody fusion (IBF) devices enhanced with hydroxyapatite (HA) material.

The devices, integrated throughout with PEEK-OPTIMA® HA Enhanced material from Invibio Biomaterial Solutions, are a next-gen version of Talos IBF that was cleared in 2009 for U.S. market launch in 2010. Meditech has employed HA PEEK in its cervical IBF implants since 2015.

Meditech will introduce six lumbar IBF footprints of Talos®-P (HA), Talos®-P WB (HA), Talos®-T (HA), Talos®-TL (HA), Talos®-A (HA) and Talos®-L (HA) within 2017.

Source: Meditech Spine LLC

Product Labels: Lumbar Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory