Vendor/Manufacturer: Medtronic Sofamor Danek
Product/Product Line: CATALYFTâ„¢ PL Expandable Interbody System
Vendor/Manufacturer Catalog #: 981315535
Global Unique Device (GUD) Primary Device Identifier Number: 00763000465957
Global Unique Device (GUD) Device Description:
SCREW 981315535 DIAMOND TIP 5.5 X 35MM
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Bone-screw internal spinal fixation system, sterile
Global Medical Device Nomenclature (GMDN) Definition:
An assembly of 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. Sterile disposable devices associated with implantation may be included.
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): KWQ, MAX
FDA Classification Product Code Device Name(s):
KWQ: Appliance, Fixation, Spinal Intervertebral Body
MAX: Intervertebral fusion device with bone graft, lumbar
FDA Premarket Submission: K210425 , K212653 The Medtronic Sofamor Danek CATALYFTâ„¢ PL Expandable Interbody System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Artic-Lâ„¢ 3D Ti Spinal System 2. Artic-XLâ„¢ 3D Ti Spinal System 3. Elevateâ„¢ Spinal System 4. Crescentâ„¢ Spinal System 5. Clydesdaleâ„¢ Spinal System
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