Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

Computer, Diagnostic, Pre-Programmed, Single-Function

FDA classification

FDA Class 2 ·Computer, Diagnostic, Pre-Programmed, Single-Function

Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System

FDA 510(k)

FDA Class 2 ·Orthopedic

Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);

FDA 510(k)

FDA Class 2 ·Radiology

Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

FDA classification

FDA Class 2 ·Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer

Catheter, Oximeter, Fiber Optic, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Oximeter, Fiber Optic, Reprocessed

Trocar, Reprocessed

FDA classification

FDA Class 2 ·Trocar, Reprocessed

Needle And Needle Set, Gastro-Urology, Reprocessed

FDA classification

FDA Class 2 ·Needle And Needle Set, Gastro-Urology, Reprocessed

Catheter, Steerable, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Steerable, Reprocessed

Needle, Hypodermic, Single Lumen, Reprocessed

FDA classification

FDA Class 2 ·Needle, Hypodermic, Single Lumen, Reprocessed

Injector And Syringe, Angiographic, Reprocessed

FDA classification

FDA Class 2 ·Injector And Syringe, Angiographic, Reprocessed

Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

FDA classification

FDA Class 2 ·Set, Dialysis, Single Needle With Uni-Directional Pump, Reprocessed

Actuator, Syringe, For Injector, Reprocessed

FDA classification

FDA Class 2 ·Actuator, Syringe, For Injector, Reprocessed

Drills, Burrs, Trephines And Accessories (Manual), Reprocessed

FDA classification

FDA Class 2 ·Drills, Burrs, Trephines And Accessories (Manual), Reprocessed

Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

FDA classification

FDA Class 2 ·Drills, Burrs, Trephines And Accessories (Simple Powered), Reprocessed

Needle, Isotope, Reprocessed

FDA classification

FDA Class 2 ·Needle, Isotope, Reprocessed

Oximeter, Tissue Saturation, Reprocessed

FDA classification

FDA Class 2 ·Oximeter, Tissue Saturation, Reprocessed

Catheter, Intracardiac Mapping, High-Density, Reprocessed

FDA classification

FDA Class 2 ·Catheter, Intracardiac Mapping, High-Density, Reprocessed

Guidewire, Catheter, Reprocessed

FDA classification

FDA Class 2 ·Guidewire, Catheter, Reprocessed

Clamp, Vascular, Reprocessed

FDA classification

FDA Class 2 ·Clamp, Vascular, Reprocessed