Medtronic Sofamor Danek ENDOSKELETON TCS NANOLOCK™ Interbody Fusion Devices. Catalog #5301-3514

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May 15, 20242 min read

Vendor/Manufacturer: Medtronic Sofamor Danek

Product/Product Line: ENDOSKELETON TCS NANOLOCK™

Interbody Fusion System

Vendor/Manufacturer Catalog #: 5301-3514

Global Unique Device (GUD) Primary Device Identifier Number:

00191375011347

Global Unique Device (GUD) Device Description:

Bone Screw, Standard, 3.5mm x 14mm

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Spinal bone screw, non-bioabsorbable

Global Medical Device Nomenclature (GMDN) Definition:

A small, threaded, implantable rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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: OVE

FDA Classification Product Code Device Name:

Intervertebral fusion device with integrated fixation, cervical

FDA Premarket Submissions: K183557 , K151596 , K153122 , K173535 , K192018