BIODENTA CUSTOMIZED ABUTMENT

FDA 510(k)

FDA Class 2 ·Dental

NextAR™ Spine Platform

FDA 510(k)

FDA Class 2 ·Neurology

Straumann BLX Variobase Abutment

FDA 510(k)

FDA Class 2 ·Dental

Trabis

FDA 510(k)

FDA Class 2 ·Orthopedic

icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)

FDA 510(k)

FDA Class 2 ·Orthopedic

Humeral Eccentric Reverse Metaphysis

FDA 510(k)

FDA Class 2 ·Orthopedic

NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft Plate

FDA 510(k)

FDA Class 2 ·Orthopedic

Pekkton Ivory

FDA 510(k)

FDA Class 2 ·Dental

Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)

FDA 510(k)

FDA Class 2 ·Orthopedic

Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers

FDA 510(k)

FDA Class 2 ·Orthopedic

MectaLock Ti Suture Anchor

FDA 510(k)

FDA Class 2 ·Orthopedic

Amis K Long

FDA 510(k)

FDA Class 2 ·Orthopedic

Glenoid Reconstruction System

FDA 510(k)

FDA Class 2 ·Orthopedic

LEVO COMPACT-EASY LCE

FDA 510(k)

FDA Class 2 ·Physical Medicine

Robotic Integration Instruments

FDA 510(k)

FDA Class 2 ·Neurology

Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated)

FDA 510(k)

FDA Class 2 ·General Hospital

Straumann CARES P-Series CAD/CAM System

FDA 510(k)

FDA Class 2 ·Dental

Vario 8/18/ci

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

PERLA® TL Posterior Thoraco-lumbar Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

NobelZygoma PureSet™ Tray

FDA 510(k)

FDA Class 2 ·General Hospital