Skip to content Skip to footer
ABANZA

ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Shots: The US FDA has granted 510(k) clearance to ABANZA’s QuadLock Fixation System, a knotless, bidirectional, tension-adjustable device for anterior cruciate ligament (ACL) reconstruction In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated <0.5 mm cyclic displacement representing a >500% reduction in cyclic displacement and >1,000 N pullout strength vs conventional fixation methods QuadLock is…

Read more

BlueOcean Global Receives US FDA 510(k) Clearance for Excelsior External Fixation System

Shots: The US FDA has granted 510(k) clearance to BlueOcean Global’s Excelsior External Fixation System, a circular external fixation platform designed to support both bone reconstruction and soft tissue management The system is cleared for commercial distribution in the US and will be rolled out initially through select centers, with broader availability planned in the…

Read more

Medivis

The US FDA Grants 510(k) Clearance to Medivis’ Spine Navigation Platform

Shots: The US FDA has granted 510(k) clearance to Spine Navigation platform; commercially launched in the US, making it available nationwide to hospitals & ambulatory surgical centers Spine Navigation integrates AI-driven surgical intelligence, real-time insights, & advanced imaging with lightweight AR hardware allowing surgeons ergonomic freedom using hand tracking & voice control in neuro &…

Read more

ABANZA

ABANZA Reports the US FDA 510(k) Clearance of WasherCap Mini for Orthopedic Surgeries

Shots: The US FDA has granted 510(k) clearance to WasherCap Mini (knotless suture & tape fixation) system, allowing bidirectional tension control in various procedures incl. meniscal root repair & ACL reconstruction WasherCap Mini has provided superior fixation strength & reduced displacement during cyclic loading compared to traditional devices in biomechanical testing, independent of the…

Read more