Legal & Regulatory and Reimbursement Archives

Legal & Regulatory and Reimbursement

SpineCraft Announces U.S. FDA 510(k) Clearance of Comprehensive ORIO-3D Trabecular Interbody Platform

by TJ Halvorson May 11, 2026May 11, 2026

Company News

Spinal Resources, Inc. Awarded Second U.S. Patent for Multi-Diameter Spinal Fixation Rod, Establishing a Layered IP Position

by TJ Halvorson May 7, 2026May 7, 2026

Legal & Regulatory and Reimbursement

Regeneration, ReNu®, and the Race Against Knee OA

by Elizabeth Hofheinz, M.P.H., M.Ed. May 6, 2026May 8, 2026

Large Joints and Extremities

FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135® Easytech Shoulder System

by TJ Halvorson May 6, 2026May 6, 2026

Legal & Regulatory and Reimbursement

Theradaptive Secures FDA Approval to Advance OASIS Trial to Pivotal Study Evaluating OsteoAdapt® SP in Spinal Fusion

by TJ Halvorson April 30, 2026April 30, 2026

Large Joints and Extremities

Organogenesis Completes Rolling Submission of Biologics License Application for ReNu®

by TJ Halvorson April 30, 2026April 30, 2026

Legal & Regulatory and Reimbursement

Life Spine Announces Expanded Indications for ARx® SAI Spinal Fixation System

by TJ Halvorson April 30, 2026April 30, 2026

Large Joints and Extremities

Capitan Orthopedics, Inc. Announces Breakthrough Device Designation for its SupraSpacer™ Implant

by TJ Halvorson April 30, 2026April 30, 2026

Company News

Medtronic announces CE Mark for Stealth AXiS™ surgical system

by TJ Halvorson April 28, 2026April 28, 2026

Legal & Regulatory and Reimbursement

Avatar Medical Receives FDA 510(k) Clearance for Avatar Medical Vision, the First Software Cleared for Use with Glasses-Free 3D Medical Displays

by TJ Halvorson April 28, 2026April 29, 2026

Legal & Regulatory and Reimbursement

Theragen Receives First European Patent for ActaStim®-S

by TJ Halvorson April 28, 2026April 28, 2026

Legal & Regulatory and Reimbursement

Zimmer Biomet Receives FDA Clearance for Expanded Reverse Shoulder Systems

by TJ Halvorson April 17, 2026April 17, 2026

Legal & Regulatory and Reimbursement

SurGenTec Secures FDA 510(k) Clearance for TiLink™ SI joint fusion- Now Navigation Compatible

by TJ Halvorson April 15, 2026April 15, 2026

Legal & Regulatory and Reimbursement

CarboFix Spine Announces FDA Clearance of CarboClear® Hybrid Posterior Cervical Screw System

by Carl Stearns April 15, 2026April 24, 2026

Extremities

Biodynamik Receives FDA IDE Approval for Pivotal U.S. Trial of XT3 System in Diabetic Foot Ulcers

by TJ Halvorson April 7, 2026April 7, 2026

Spine

Orthomod Announces FDA Clearance of MOD-C™ Cervical Implant, Debuting Novel CAMP™ Biomaterial

by TJ Halvorson April 7, 2026April 24, 2026

Legal & Regulatory and Reimbursement

Highridge Medical Announces Landmark Positive Policy Decision for The Tether™ Vertebral Body Tethering System

by TJ Halvorson April 1, 2026April 1, 2026

Legal & Regulatory and Reimbursement

Spectrum Spine Inc Earns FDA Clearance for Next Generation Nanotechnology – BioBraille™

by TJ Halvorson April 1, 2026April 1, 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

2nd FDA Clearance for Novel Instrument Sterilization System

by Elizabeth Hofheinz, M.P.H., M.Ed. March 2, 2026March 5, 2026

Legal & Regulatory and Reimbursement

FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

by Elizabeth Hofheinz, M.P.H., M.Ed. March 2, 2026February 27, 2026

Legal & Regulatory and Reimbursement

Synergy Spine Solutions® Receives FDA Approval for its Synergy Disc®, Expanding Cervical Disc Replacement Options for U.S. Patients

by TJ Halvorson February 27, 2026February 27, 2026

Legal & Regulatory and Reimbursement

Kneevoice Receives FDA 510(k) Clearance for Innovative Cartilage Auscultation System

by TJ Halvorson February 27, 2026February 27, 2026

Legal & Regulatory and Reimbursement

Catalyst OrthoScience Announces FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty

by TJ Halvorson February 26, 2026February 26, 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

MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System

by TJ Halvorson February 24, 2026February 24, 2026

Legal & Regulatory and Reimbursement

FDA Clears IST’s ONE TRAY® for 365 Day Storage, Expanding Sterilization Flexibility for Surgical Facilities

by TJ Halvorson February 20, 2026February 20, 2026

Legal & Regulatory and Reimbursement

Medtronic’s Next Gen Intelligent Spine Platform Unveiled

by Elizabeth Hofheinz, M.P.H., M.Ed. February 19, 2026February 18, 2026

Legal & Regulatory and Reimbursement

Medtronic Announces FDA approval of Infuse™ bone graft for one-and-two level Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures

by TJ Halvorson February 17, 2026February 18, 2026

Category: Legal & Regulatory and Reimbursement

SpineCraft Announces U.S. FDA 510(k) Clearance of Comprehensive ORIO-3D Trabecular Interbody Platform

Spinal Resources, Inc. Awarded Second U.S. Patent for Multi-Diameter Spinal Fixation Rod, Establishing a Layered IP Position

Regeneration, ReNu®, and the Race Against Knee OA

FX Shoulder Solutions, Inc. Receives FDA 510(k) Clearance for FX V135® Easytech Shoulder System

Theradaptive Secures FDA Approval to Advance OASIS Trial to Pivotal Study Evaluating OsteoAdapt® SP in Spinal Fusion

Organogenesis Completes Rolling Submission of Biologics License Application for ReNu®

Life Spine Announces Expanded Indications for ARx® SAI Spinal Fixation System

Capitan Orthopedics, Inc. Announces Breakthrough Device Designation for its SupraSpacer™ Implant

Medtronic announces CE Mark for Stealth AXiS™ surgical system

Avatar Medical Receives FDA 510(k) Clearance for Avatar Medical Vision, the First Software Cleared for Use with Glasses-Free 3D Medical Displays

Theragen Receives First European Patent for ActaStim®-S

Zimmer Biomet Receives FDA Clearance for Expanded Reverse Shoulder Systems

SurGenTec Secures FDA 510(k) Clearance for TiLink™ SI joint fusion- Now Navigation Compatible

CarboFix Spine Announces FDA Clearance of CarboClear® Hybrid Posterior Cervical Screw System

Biodynamik Receives FDA IDE Approval for Pivotal U.S. Trial of XT3 System in Diabetic Foot Ulcers

Orthomod Announces FDA Clearance of MOD-C™ Cervical Implant, Debuting Novel CAMP™ Biomaterial

Highridge Medical Announces Landmark Positive Policy Decision for The Tether™ Vertebral Body Tethering System

Spectrum Spine Inc Earns FDA Clearance for Next Generation Nanotechnology – BioBraille™

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

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

2nd FDA Clearance for Novel Instrument Sterilization System

FDA Approves (PMA) Dynamic Sagittal Tethering for Spondy

Synergy Spine Solutions® Receives FDA Approval for its Synergy Disc®, Expanding Cervical Disc Replacement Options for U.S. Patients

Kneevoice Receives FDA 510(k) Clearance for Innovative Cartilage Auscultation System

Catalyst OrthoScience Announces FDA 510(k) Clearance of Archer® Patient-Specific Instrumentation for Shoulder Arthroplasty

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

MiRus® Receives FDA 510(k) Clearance for IO™ Expandable Wedge Osteotomy System

FDA Clears IST’s ONE TRAY® for 365 Day Storage, Expanding Sterilization Flexibility for Surgical Facilities

Medtronic’s Next Gen Intelligent Spine Platform Unveiled

Medtronic Announces FDA approval of Infuse™ bone graft for one-and-two level Transforaminal Lumbar Interbody Fusion (TLIF) spine procedures

The Promise of Biomimetic Implant Surfaces & Nano + Femtosecond Laser Texturing

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