Orthofix (Nasdaq: OFIX) today announced it received FDA 510(k) clearance for the Fitbone Transport and Lengthening System and reported the first implant of the device.
Globus Medical has won FDA clearance for its new ExcelsiusFlex orthopedics robot stereotaxic surgery in knee procedures and an expanded indication for its ExcelsiusHub system.
The potential benefits of utilizing the CORUS™ Navigation Access System to perform a navigated CORUS fusion include:
> Enhanced accuracy and precision with surgical instruments and spinal implants, e.g., CAVUX FFS-LX.
> Improved visualization of the facet joints and other anatomical structures during procedures.
> Reduced risk of complications and shorter operative time.
Medical imaging AI company receives approval for algorithm enabling opportunistic detection and triage of vertebral compression fractures.
Canary Medical announced today that it received FDA breakthrough device designation for its Canturio lumbar cartridge.
Medtronic (NYSE: MDT)+
announced today that the FDA granted breakthrough device designation for its Infuse bone graft.
ADDISON, Texas , May 16, 2024 /PRNewswire/ — FX received 510k clearance for its full-wedge augmented glenoid baseplates. The newly cleared baseplates bring 6 new options to the previously cleared portfolio. There are now a combined total of 18 glenoid baseplate options to the market to address a variety of surgeon needs. Augmented glenoid baseplate options have continued to become a growing solution for surgeons to address bone loss, defects, or complicated morphologies of the glenoid.
Orthofix (Nasdaq: OFIX)+
today announced it received FDA 510(k) clearance for its Rodeo Telescopic Nail.
OrthoXel announced that it received FDA 510(k) clearance for its Vertex hip fracture nail (HFN) for fracture fixation.
MISGAV, Israel, May 6, 2024 /PRNewswire/ — ZygoFix Ltd. a portfolio company of The Trendlines Group Ltd. (“Trendlines”) announced that it received regulatory clearance from the United States Food and Drug Administration (FDA clearance) for its zLOCK Lumbar Facet Fixation System. This achievement was supported by compelling clinical evidence from the company’s ongoing European clinical study, marking a significant advancement in spinal fusion technology..