#510clearance Archives - Orthopedics This Week

Pace Surgical Receives FDA 510(k) Clearance for Ultra Compression Screw System for Foot and Ankle Reconstruction

by TJ Halvorson November 12, 2025November 12, 2025

Large Joints and Extremities

Twinsight Receives FDA 510(k) Clearance for SurgiTwin™

by TJ Halvorson September 29, 2025October 25, 2025

Legal & Regulatory and Reimbursement

FDA Clears Truly Novel 3D Printed PEEK Spinal Implant

by Kim DelMonico March 2, 2023November 1, 2024

Legal & Regulatory and Reimbursement

510(k) Clearance for Shoulder System With Ellipsoid Anatomic Head

by Kim DelMonico March 2, 2023November 1, 2024

Legal & Regulatory and Reimbursement

Ulna Intramedullary Nail System Gets 510(k) Clearance

by Kim DelMonico February 2, 2023November 1, 2024

Legal & Regulatory and Reimbursement

FDA Clears Mechanical Integration Pedicle Screw System

by Kim DelMonico December 1, 2022November 1, 2024

Legal & Regulatory and Reimbursement

Medtronic’s Evolving 3-D Mazor Platform Gets New FDA Clearance

by Walter Eisner January 7, 2021October 24, 2024

Legal & Regulatory and Reimbursement

FDA Clears Stryker 3D Expandable Interbody System

by Walter Eisner November 20, 2019November 1, 2024

Legal & Regulatory and Reimbursement

FDA Clears Pro Macrophage Spinal Implant

by Walter Eisner November 15, 2019November 1, 2024

Legal & Regulatory and Reimbursement

SIG Medical’s Rib Fracture Repair System Cleared by FDA

by Walter Eisner March 7, 2019November 1, 2024

Legal & Regulatory and Reimbursement

FDA Forecast and Analysis for 2019

by Walter Eisner January 9, 2019October 24, 2024

Legal & Regulatory and Reimbursement

Gov’t Shutdown Delays Device Applications and More

by William Donovan January 4, 2019November 1, 2024

Legal & Regulatory and Reimbursement

510(k) Overhaul Gaining Momentum at FDA

by William Donovan December 17, 2018October 24, 2024

Legal & Regulatory and Reimbursement

Are FDA Guidance Documents Nonbinding?

by Walter Eisner March 23, 2018November 1, 2024