K051320 VERTEX® Reconstruction System -Special

FDA registration

Sterigenics US, LLC·1 product·🇺🇸 United States

SOLID SPHERE

FDA registration

WARSAW ORTHOPEDIC, INC.·1 product·🇺🇸 United States

SOLID SPHERE

FDA registration

Medtronic Engineering and Innovation Center (MEIC)·1 product·🇮🇳 India

Spinal Sphere System

FDA registration

LIFE SPINE·1 product·🇺🇸 United States

SOLID SPHERE

FDA registration

MEDTRONIC SOFAMOR DANEK USA, INC.·1 product·🇺🇸 United States

Vertical Haler 3.4mm NV - R

Device

EU MDR · Eu Md Class 2a ·EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.·On the market·2 countries

Vertical Haler 3.4mm NV - R

Device

EU MDD · Eu Md Class 1 ·EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.·On the market

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·GORE HELEX SEPTAL OCCLUDER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN ENDOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

SPINAL STABILIZING SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

PEEK SPINAL SPHERES

FDA 510(k)

FDA Class 3 ·Unknown

MODIFICATION TO: SATELLITE SPINAL SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

SPINAL SPHERE SYSTEM

FDA 510(k)

FDA Class 3 ·Unknown

Vertical Haler 3.4mm NV - R

Basic UDI-DI

EU MDD · Eu Md Class 1 ·EMPHASYS IMPORTADORA, EXPORTADORA E DISTRIBUIDORA LTDA.·1 device