Tag: 510(k) clearance

misonix

Misonix receives US FDA clearance for integrated ultrasonic surgical platform

Misonix today announced that it received 510(k) clearance by the US Food and Drug Administration (FDA) for Nexus, its ultrasonic surgical platform. Misonix will...

Alphatec announces FDA clearance of automated SafeOp neuromonitoring system

It was announced recently that Alphatec has received 510(k) clearance from the US Food & Drug Administration (FDA) for its automated SafeOp neuromonitoring system for use...

NuVasive’s Porous PEEK impant to be used in flagship XLIF procedure

NuVasive has announced it has received 510(k) clearance from the US Food and Drug Administration (FDA) for use of its COHERE Porous PEEK implant...

Camber Spine announces 510(k) approval of ENZA-A titanium ALIF

The US Food and Drug Administration (FDA) has given 510(k) clearance to Camber Spine to market its ENZA-A titanium anterior lumbar interbody fusion (ALIF)...

Zimmer Biomet announces 510(k) clearance for Zyston strut open titanium interbody...

The US Food and Drug Administration (FDA) has given 510(k) clearance for the Zyston strut open titanium interbody spacer system (Zimmer Biomet). This marks...