Tag: FDA approvals
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...
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...
Omnia Medical gains FDA clearance for vertebral body replacement system
Omnia Medical has announced that the US Food and Drug Administration (FDA) has cleared its new vertebral body replacement (VBR) system, which is manufactured...
“Significantly more bone infiltration” with 3D-printed triangular sacroiliac joint fusion implants
The popularity of sacroiliac joint fusion has grown rapidly over the past five years, with SI-Bone’s Ifuse device leading the market. Recently approved by...
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...