Tag: US FDA

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...
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...

icotec receives FDA clearance to market BlackArmor® Carbon/PEEK interbody cages

The latest line of icotec interbody cages, designed to optimise bony integration and post-operative visualisation, has received US Food and Drug Administration (FDA) 510(k)...

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...

Europe braces for harder times in medical device innovation while US...

Countries in the European Union have long been the first to receive new innovations in medical technology, as the EU’s Medical Device Directive (MDD)...

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)...
Medicrea IB3D TB cage

IB3D 3D-printed interbody devices cleared by US FDA

Medicrea yesterday announced the clearance of their additively-manufactured IB3D titanium interbody devices by the US Food and Drug Administration (FDA), and introduced a new...
hd lifesciences nanohive alif device spinal news

NanoHive lumbar interbodies receive FDA clearance

The US Food and Drug Administration (FDA) has cleared HD Lifesciences’ NanoHive interbodies. The company released the devices to the US market last month. Each...
Zimmer Biomet

Zimmer Biomet recalls implantable spinal fusion stimulators

Zimmer Biomet has begun the process of recalling its SpF Plus-Mini and SpF XL IIb implantable spinal fusion stimulators in the USA, “due to...

US FDA clears Life Spine’s Plateau-C Ti cervical spacer system

The US Food and Drug Administration (FDA) has given 510(k) market clearance to Life Spine’s Plateau-C Ti cervical spacer system. The system utilises the company’s...

GS Medical USA announces new product portfolio

GS Medical USA has announced the confirmed and pending launch of several US Food and Drug Administration (FDA) 510(k)-approved products. The company plans to launch...

ChoiceSpine releases Harrier ALIF system

ChoiceSpine has launched Harrier, an anterior lumbar interbody fusion system. The device was cleared for marketing by the US Food and Drug Administration in...

DePuy Synthes receives US FDA clearance for cement-augmented pedicle screw systems

DePuy Synthes has received 510(k) clearance from the US Food and Drug Administration (FDA) for the Viper and Expedium fenestrated screw systems. When used...

US FDA clears Camber Spine’s Siconus sacroiliac joint fixation system

The US Food and Drug Administration has granted Camber Spine Technologies 510(k) clearance for the Siconus sacroiliac joint fixation system. Daniel Pontecorvo, founder and chief...

Whale Imaging receives US FDA approval for G-arm B6 Duo

Whale Imaging has received US Food and Drug Administration FDA 510(k) clearance for its G-Arm B6 Duo. The B6 Duo is the next generation...

Medicrea files FDA 510(k) submission for 3D-printed titanium spinal devices

Medicrea has filed a 510(k) submission to the US Food and Drug Administration (FDA) for approval of the company’s 3D-printed titanium interbody devices, with...

Robert Califf to resign as US FDA commissioner

Robert Califf is to step down as US Food and Drug Administration (FDA) commissioner upon the inauguration of Donald Trump as US President on...

US FDA clears Precision Spine’s AccuFit lateral plating system

Precision Spine has received US Food and Drug Administration (FDA) 510(k) clearance of its AccuFit lateral plating system. The AccuFit plate is designed to provide...

US FDA bans powdered gloves

The US Food and Drug Administration (FDA) has issued a final rule to ban powdered surgical gloves, patient examination gloves and the absorbable powder...

NICE collaborates with US FDA on Payer Communication Taskforce

The UK’s National Institute for Health and Care Excellence (NICE) has announced its participation in the US Food and Drug Administration (FDA)’s Payer Communication...

Signus receives US FDA 510(k) clearance for Diplomat posterior pedicle screw...

Signus has received 510(k) clearance from the US Food and Drug Administration (FDA) for the new Diplomat pedicle screw system. The Diplomat has been developed...