Tag: 510(k) clearance

Spineart receives US FDA 510(k) clearance for SCARLET AC-Ti anterior cervical...

Spineart has announced the receipt of 510(k) clearance from the US Food and Drug Administration (FDA) for its SCARLET AC-Ti secured anterior cervical cage. The...

Nevro receives US FDA 510(k) clearance to use SI fixation system...

Nevro Corporation has announced that the US Food and Drug Administration (FDA) has cleared its sacroiliac (SI) joint fusion device, which will be marketed...

Woven Orthopedic secures US FDA 510(k) clearance for larger version of...

Woven Orthopedic Technologies has received its second 510(k) clearance from the US Food and Drug Administration (FDA) for the use of the Ogmend implant enhancement...

4WEB Medical receives 510(k) clearance to market new integrated cervical plate

4WEB Medical has announced that it has received 510(k) clearance to market the newest additions to the company's implant portfolio—the Cervical Spine Truss System...
Life Spine receives approval from FDA

Life Spine receives US FDA 510(k) clearance for Steerable Plateau Ti...

Life Spine has announced that it has received 510(k) clearance from the US Food & Drug Administration (FDA) to market the Steerable Plateau Ti...
fda

GALILEO spine alignment monitoring system receives FDA clearance

MiRus has announced US Food and Drug Administration (FDA) 510(k) clearance of the GALILEO spine alignment monitoring system, a non-optical, wireless, real-time measurement system...
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...