The company’s 3rd FDA clearance accelerates the shift to AI-powered digital hematopathology, enhancing diagnostic speed and patient care
IRVING, Texas, April 16, 2024 /PRNewswire/ — Xstim, Inc., a pioneering developer and manufacturer of cutting-edge bone growth stimulation systems, is thrilled to announce its recent Premarket Application (PMA) approval from the U.S. Food and Drug Administration (FDA) for Xstim™ Spine Fusion Stimulator
The 3D printed PEEK implants using the EXT 220 MED were successfully demonstrated in nearly 40 cranioplasties across Europe in recent months says the company.
Onkos Surgical this week announced it received FDA de novo approval for its antibacterial coated implants.
Ross Bjella, Kelyniam’s CEO, said, “This approval will further boost Kelyniam’s sales momentum which started in Q4 last year
SurGenTec announced today that it received FDA 510(k) clearance for its OsteoFlo HydroPutty synthetic bone graft.
Medtronic (NYSE: MDT)+
announced today that it received FDA 510(k) clearance for its OsteoCool 2.0 bone tumor ablation system.
Nevro1™ Proven to Immediately Transfix Sacroiliac (SI) Joint to Allow for Long-term SI Joint Fusion
BETHLEHEM, Pa., Feb. 6, 2024 /PRNewswire/ — Tyber Medical LLC, a leading orthopedic device manufacturer providing private label orthopedic implants for the trauma, extremity, and spine markets, received clearance for the anatomical plating system in Canada. The comprehensive portfolio previously received FDA 510(k) in the US and has now been cleared through Health Canada.
Tyber Medical Broadens Its Vast Plating Portfolio with FDA Approval of Additional Screw and Plate Options, and Indications for Mini-Frag System