Alphatec (Atec) INVICTUSâ„¢ Spinal Fixation System. Catalog #15025-065-045
- CataBlog
- Dec 12, 2020
- 1 min read
Updated: May 1, 2024
Vendor/Manufacturer: Alphatec (Atec)
Product/Product Line: INVICTUSâ„¢ Spinal Fixation System
Vendor/Manufacturer Catalog #: 15025-065-045
Global Unique Device (GUD) Primary Device Identifier Number: 00190376117928
Global Unique Device (GUD) Device Description:
Cannulated Extended Tab Polyaxial Reduction Screw, 6.5 mm x 45 mm
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: Lumbar Pedicle Screw Systems
Category 3: Screw
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Thoracolumbosacral pedicle screw system
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
FDA Premarket Submission: K192938
The Alphatec INVICTUSâ„¢ Spinal Fixation System is
SUBSTANTIALLY EQUIVALENT to the following products:
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For more information, please visit us at Infonomics.com