510k clearance Archives - Orthopedics This Week

Bending Not Breaking: A New Spine Player Tries to Soften the Game

by Elizaabeth Hofheinz, M.P.H., M.Ed. April 6, 2026April 6, 2026

Legal & Regulatory and Reimbursement

SpinePoint Receives U.S. FDA 510(k) Clearance for Flex-Z™ Cervical Cage / First Product in the Ultra-Low Stiffness Cushioning Interbody Platform

by TJ Halvorson March 28, 2026March 28, 2026

Legal & Regulatory and Reimbursement

Spinal Elements Expands Ventana® Platform with FDA 510(k) Clearance and First Cases of Ventana® A ALIF System

by TJ Halvorson March 19, 2026March 19, 2026

Legal & Regulatory and Reimbursement

4WEB Medical Receives 510(k) Clearance to Market its New SI Joint Truss System™

by TJ Halvorson February 25, 2026February 25, 2026

Legal & Regulatory and Reimbursement

SurGenTec® Secures FDA Clearance for ION-C™ Facet Fixation System — Designed to Support Fusion While Preserving Alignment

by TJ Halvorson January 21, 2026January 21, 2026

Legal & Regulatory and Reimbursement

Curiteva Receives FDA Nano Designation for Inspire 3D Printed Trabecular PEEK Technology

by TJ Halvorson January 20, 2026January 20, 2026

Spine

Cresco Spine Receives FDA 510(k) Clearance for the Spring Distraction System (SDSTM)

by TJ Halvorson January 19, 2026February 13, 2026

FDA Clears Toetal Solution’s Ziptoe Hammertoe System

by TJ Halvorson January 8, 2026January 23, 2026