FDA 510(k) Clearance for NanoFUSE BA

By Julie A. Vetalice

Amend Surgical received FDA 510(k) clearance to market NanoFUSE® BA as a bone graft extender for spine and orthopaedic applications.

The bioactive glass-based product represents the second FDA-cleared product for Amend, the first being NanoFUSE DBM, for which worldwide licensing rights were granted to Amend Surgical by Nanotherapeutics.

Amend Surgical's development pipeline includes novel clinically-evaluated osteoinductive bone extracts.

Sources: Amend Surgical, Inc.; amendsurgical.com; ORTHOWORLD Inc.

Product Labels: Bone Graft Materials/DBM

Tags: 510(k) Clearance, Regulatory