Tag: FDA approval
Swiss parliament votes to accept US FDA-approved medical devices
The Swiss Federal Assembly has voted in favour of accepting medical devices with US Food and Drug Administration (FDA) marketing authorisation in Switzerland.
A motion...
Nevro announces US FDA approval of HFX iQ system to personalise...
Nevro Corporation has announced that it has received approval from the US Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS)...
Abbott gains US FDA approval for Proclaim Plus spinal cord stimulation...
Abbott has announced that the US Food and Drug Administration (FDA) has approved its new Proclaim Plus spinal cord stimulation (SCS) system featuring FlexBurst360...
High-frequency SCS takes the stage to relieve chronic pain from diabetic...
Following the recent approval of the Senza system (Nevro) by the US Food and Drug Administration (FDA), Erika A Petersen (Little Rock, USA) discusses the...
Nevro announces FDA approval of high-frequency SCS therapy for painful diabetic...
Nevro has announced receipt of US Food and Drug Administration (FDA) approval for its Senza system to treat chronic pain associated with painful diabetic...
CarboFix announces FDA clearance of Vertebral Body Replacement (VBR) System
CarboFix has announced that the US Food and Drug Administration (FDA) has cleared its CarboClear Carbon Fiber Vertebral Body Replacement (VBR) System to replace...
Medtronic announce new clinical trial to study Infuse bone graft in...
Medtronic today announced US Food and Drug Administration (FDA) approval of a prospective, randomised pivotal clinical trial for the use of Infuse bone graft...
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...
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 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...
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...
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...
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...