BonOs® Inject Bone Cement; NEO Pedicle Screw System™

FDA 510(k)

FDA Class 2 ·Orthopedic

BonOs Inject Bone Cement; NEO Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set

FDA 510(k)

FDA Class 2 ·Orthopedic

CONFIDENCE™ High Viscosity Spinal Cement, VIPER® and EXPEDIUM® Fenestrated Screw Systems

FDA 510(k)

FDA Class 2 ·Orthopedic

G21 Cement, VADER® Pedicle System

FDA 510(k)

FDA Class 2 ·Orthopedic

CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

NuVasive Reline Fenestrated Screws, High V+ Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

PERLA® TL System; TEKTONA® HV US Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

Invictus® Bone Cement, Invictus Spinal Fixation System

FDA 510(k)

FDA Class 2 ·Orthopedic

VADER® Pedicle System, G21 Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System

FDA 510(k)

FDA Class 2 ·Orthopedic

High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws

FDA 510(k)

FDA Class 2 ·Orthopedic

KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set

FDA 510(k)

FDA Class 2 ·Orthopedic

KYPHON Xpede Bone Cement, CD HORIZON Fenestrated Screw Set

FDA 510(k)

FDA Class 2 ·Orthopedic

Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum® MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement

FDA 510(k)

FDA Class 2 ·Orthopedic

Vertaplex HV High Viscosity Radiopaque Bone Cement; ES2 Augmentable Spinal System

FDA 510(k)

FDA Class 2 ·Orthopedic

Pasteur Pipette 3mL, Pasteur Pipette 1mL

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML

FDA 510(k)

FDA Class 2 ·General Hospital

Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)

FDA 510(k)

FDA Class 2 ·Gastroenterology, Urology