Depuy Synthes ANTEGRA Plate System. Catalog #04.201.026
- CataBlog
- Apr 30, 2024
- 1 min read
Vendor/Manufacturer: Depuy Synthes
Product/Product Line: ANTEGRA Plate System
Vendor/Manufacturer Catalog #: 04.201.026
Global Unique Device (GUD) Primary Device Identifier Number:
10705034733852
Global Unique Device (GUD) Device Description:
6.0MM TI CANCELLOUS LOCKING SCREW W/STARDRIVE RECESS 26MM
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
Category 1: Spine
Category 2: Thoracolumbar Plate and Screw System
Category 3: Screw
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: KWQ
FDA Classification Product Code Device Name:
Appliance, Fixation, Spinal Intervertebral Body
FDA Premarket Submission: K063158
The Globus Medical PLYMOUTH Thoracolumbar Plate System is
SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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