Orthofix CONSTRUX® Mini PEEK Spacer System. Catalog #47-4014C

CataBlog
Apr 27, 2024
2 min read

Vendor/Manufacturer: Orthofix

Product/Product Line: CONSTRUX® Mini PEEK Spacer System

Vendor/Manufacturer Catalog #: 47-4014C

Global Unique Device (GUD) Primary Device Identifier Number:

18257200042234

Global Unique Device (GUD) Device Description:

CONSTRUX MINI 15MM W X 12MM D X 14MM H, 5 DEGREE LORDOTIC

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metallic spinal interbody fusion cage

Global Medical Device Nomenclature (GMDN) Definition:

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name:

Intervertebral body fusion device

FDA Classification Product Code(s): MQP, ODP

FDA Classification Product Code Device Name(s):

MQP: Spinal Vertebral Body Replacement Device

ODP: Intervertebral Fusion Device With Bone Graft, Cervical

FDA Premarket Submission: K202949 , K101812 , K172437

The Orthofix CONSTRUX® Mini PEEK Spacer System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. SureMAX™ Family of Cervical Spacers