Tag: FDA approval

Zimmer Biomet Spine announces FDA approval of Mobi-C cervical disc labelling...

  Zimmer Biomet has announced that the US Food and Drug Administration (FDA) has approved an extension to the Mobi-C Cervical Disc labelling to include...

Bio2 Technologies receives FDA IDE approval to begin clinical study of...

Bio2 Technologies, a privately held orthopaedics company, has announced that it received US Food and Drug Administration (FDA) approval to begin enrolment in an...
Sphynx

FDA approval granted for Eden Spine’s Sphynx

Eden Spine’s Sphynx plating system has been granted FDA clearance, the company has announced. Sphynx was designed to complement the company’s Giza titanium vertebral body...
NuVasive

NuVasive unveils spine’s first integrated surgical automation platform

NuVasive has announced the Pulse surgical automation platform has received 510(k) clearance from the US Food and Drug Administration (FDA). Pulse is the foundation...
nanotechnology

FDA clears first nanotechnology PEEK devices for spinal intervertebral fusion

The US Food and Drug Administration (FDA) has granted approval to market a polyetheretherketone (PEEK) spinal interbody fusion device with a PEEKplus nanotextured surface...
LifeSciences

FDA clearance granted for Hive-C cervical interbody devices

HD LifeSciences has received FDA 510(k) clearance for its Hive-C IBFD, a system of interbody devices for anterior cervical fusion procedures. The Hive-C implant system...
Tesera

Renovis Surgical receives FDA clearance for Tesera Trabecular Technology Hyperlordotic ALIF...

  Renovis Surgical Technologies has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market the Tesera SA...

First patented single implant sacroiliac joint fusion system receives FDA clearance

The US Food and Drug Administration (FDA) have granted clearance for the Catamaran sacroiliac joint fixation system (Tenon Medical) specifically indicated for sacroiliac joint...

Bone cement solution indicated for treating sacral fractures granted FDA approval

The US Food and Drug Administration (FDA) has granted 510(k) clearance of Kyphon HV-R bone cement (Medtronic) for fixation of pathological fractures of the...

Paradigm Spine receives FDA pre-market approval (PMA) for first of its...

The US Food and Drug Administration (FDA) has granted pre-market supplemental approval (PMA) for the coflex interlaminar stabilisation disposable instrument kit (Paradigm Spine). This...

Rampart One standard ALIF interbody fusion system gains FDA clearance for...

The Rampart One Standard anterior lumbar interbody fusion (ALIF) device (Spineology) has been granted FDA clearance, allowing it to be used with or without...

FDA 510(k) clearance for cervical and lumbar HA PEEK interbody...

The US Food and Drug Administration (FDA) has granted 510(k) clearance for both the ALTA ACDF interbody spacers (Astura Medical) and HALF DOME lumbar...

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)...

FDA approval for Infuse Bone Graft in expanded spinal surgery indications

Infuse Bone Graft (Medtronic) has gained US Food and Drug Administration (FDA) approval in new spine surgery indications. InfuseBone Graft is now approved for...

CTL Medical secures FDA approval for its MATISSE Titanium-PEEK ACIF cage...

CTL Medical, a Dallas-based medical device manufacturing and service company, has secured US Food and Drug Administration (FDA) clearance and approval to market its...