Altus Spine VALENCIA MIS Pedicle Screw System. Catalog #923-5040

Vendor/Manufacturer: Altus Spine

Product/Product Line: VALENCIA MIS Pedicle Screw System

Vendor/Manufacturer Catalog #: 923-5040

Global Unique Device (GUD) Primary Device Identifier Number:

B41792350401

Global Unique Device (GUD) Device Description:

5.5mm x 40mm Curved Rod

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Orthopaedic instrument surgical connector

Global Medical Device Nomenclature (GMDN) Definition:

A small device designed to be used during a surgical procedure to make a physical connection between two orthopaedic instruments, instrument components, or an orthopaedic instrument and another device (e.g., an implant) to facilitate the insertion and placement of implantable devices (e.g., pins, nails, screws, blades) into bone or to achieve a procedure goal (e.g., bone fracture compression). It is typically made of metal and in one of several forms (e.g., screw, nut, threaded rod). This is a reusable device.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3060

FDA Regulation Description Classification Name:

Spinal intervertebral body fixation orthosis

FDA Classification Product Code(s): KWP, KWQ, MNH, MNI, NKB

FDA Classification Product Code Device Name(s):

KWP: Appliance, Fixation, Spinal Interlaminal

KWQ: Appliance, Fixation, Spinal Intervertebral Body

MNH: Orthosis, Spondylolisthesis Spinal Fixation

MNI: Orthosis, Spinal Pedicle Fixation

NKB: Thoracolumbosacral Pedicle Screw System

FDA Premarket Submission: K151648 The Altus Spine VALENCIA MIS Pedicle Screw System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. DePuy Viper 2 System

2. CoreLink Tiger Spine System

3. Altus Spine Pedicle Screw System

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