POLARIS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

GALLERY LAMINOPLASTY FIXATION SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

MYKRES SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXTGEN ALTIUS OCT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM - BALLISTA II PERCUTANEOUS SCREW PLACEMENT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM - BALLISTA II RODS

FDA 510(k)

FDA Class 2 ·Orthopedic

ZYSTON ARC INTERBODY SPACER

FDA 510(k)

FDA Class 2 ·Orthopedic

NEXTGEN ALTIUS OCT SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

POLARIS SPINAL SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET LATERAL SPACER SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIOMET ACCESS SYSTEM

FDA 510(k)

FDA Class 2 ·Ear, Nose, Throat

MAXAN ANTERIOR CERVICAL PLATE SYSTEM

FDA 510(k)

FDA Class 2 ·Orthopedic

BIO SDP (AKA SATURN SD, GLC-III SD & STAT-SD)

FDA 510(k)

FDA Class 2 ·Neurology

SECTOR & TRANSVAGINAL MODEL #'S SW4/5B/A,EW5/7K/A

FDA 510(k)

FDA Class 2 ·Radiology

IMAGE-IGE

FDA 510(k)

FDA Class 2 ·Immunology

2-in-1 Abdominal Muscle Training & Back Pain Relief System

FDA 510(k)

FDA Class 2 ·Neurology

KAY-PLUS & VARIOUS VANIA SANITARY LINERS & PADS

FDA 510(k)

FDA Class 2 ·Obstetrics/Gynecology

ClearPath Disposable Introducer

FDA 510(k)

FDA Class 2 ·Neurology

Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex Screws

FDA 510(k)

FDA Class 2 ·Orthopedic