Humeris® 135 Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

Humeral Cup Stability & Humeral Cup 135/145o Stability

FDA 510(k)

FDA Class 2 ·Orthopedic

Glenoid Baseplate with Screw

FDA 510(k)

FDA Class 2 ·Orthopedic

32mm Glenosphere and Humeral Cup

FDA 510(k)

FDA Class 2 ·Orthopedic

Humelock TiN Coated Glenosphere

FDA 510(k)

FDA Class 2 ·Orthopedic

FX V135 Shoulder Prosthesis

FDA 510(k)

FDA Class 2 ·Orthopedic

Easytech® Anatomical Shoulder System

FDA 510(k)

FDA Class 2 ·Orthopedic

EXTERNAL FIXATION RING

FDA 510(k)

FDA Class 2 ·Orthopedic

Full Wedge Lateralized and Augmented Baseplates

FDA 510(k)

FDA Class 2 ·Orthopedic

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·NINJA FX PTCA DILATATION CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FX MINIRAIL RX PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FX MINIRAIL PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·FX MINIRAIL RX PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER

VITASCORE

FDA 510(k)

FDA Class 2 ·Anesthesiology

Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

FDA classification

FDA Class 2 ·Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene