Alphatec (Atec) INVICTUS™ Spinal Fixation System. Catalog #CI-10509

Vendor/Manufacturer: Alphatec (Atec)

Product/Product Line:  INVICTUS™ Spinal Fixation System 

Vendor/Manufacturer Catalog #: CI-10509

Global Unique Device (GUD) Primary Device Identifier Number: 

00811801031441

Global Unique Device (GUD) Device Description: 

Invictus NI Awl

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone awl, reusable

Global Medical Device Nomenclature (GMDN) Definition:

A spike-like, manual, orthopaedic surgical instrument intended to bore holes in bone. It is a straight or slightly curve rod-like instrument with a sharp, trocar-like point at the distal end and a T-shaped handle at the proximal end, typically made of metallic and/or synthetic material. This is a reusable device.

FDA Regulation Medical Specialty: 

Neurological Devices - Stereotaxic instrument

FDA Regulation Number: 882.4560

FDA Regulation Description Classification Name: 

Stereotaxic instruments

FDA Classification Product Code: OLO

FDA Classification Product Code Device Name: 

Orthopedic Stereotaxic Instrument

FDA Premarket Submissions: K153603 

The Alphatec (Atec) INVICTUS™ Spinal Fixation System is

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Medtronic Navigation CD Horizon Solera Screwdrivers and Taps 

SEARCH FOR THESE PRODUCTS

For more information, please visit us at Infonomics.com