Home GUDID M555512195025 Taurus Pedicle Screw System
Primary DI M555512195025
Brand Taurus Pedicle Screw System
Company SINTX Technologies, Inc.
Model X
Catalog number 51-2195-025
Device description Taurus Pedicle Screw System- Screw, Pedicle, DL Cannulated Dia 9.5mm x 25mm
Published 2018-08-31
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name KWP Appliance, Fixation, Spinal Interlaminal KWQ Appliance, Fixation, Spinal Intervertebral Body MNH Orthosis, Spondylolisthesis Spinal Fixation MNI Orthosis, Spinal Pedicle Fixation
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KWP Appliance, Fixation, Spinal Interlaminal Orthopedic 2 KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic 2 MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic 2 MNI Orthosis, Spinal Pedicle Fixation Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M555512195025 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Bone-screw internal spinal fixation system, non-sterile 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.
Device Sizes# Type, Value, Unit table Type Value Unit Length 25 Millimeter Outer Diameter 9.5 Millimeter
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 028629553 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published G817103151100 SiNAPTIC Osteotomy Wedge System Inserter - Rev. 0 103-15-1100 2026-04-06 G817103151200 SiNAPTIC Osteotomy Wedge System Tamp - Rev. 0 103-15-1200 2026-04-06 G81711325121605 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121605 2026-04-06 G81711325121606 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121606 2026-04-06 G81711325121607 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121607 2026-04-06 G81711325121608 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121608 2026-04-06 G81711325121610 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121610 2026-04-06 G81711325121612 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-121612 2026-04-06 G81711325141805 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141805 2026-04-06 G81711325141806 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141806 2026-04-06 G81711325141807 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141807 2026-04-06 G81711325141808 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141808 2026-04-06 G81711325141810 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141810 2026-04-06 G81711325141812 SiNAPTIC Osteotomy Wedge System Cotton Trial - Rev. 0 113-25-141812 2026-04-06 G817S101181806 SiNAPTIC Osteotomy Wedge System Evans Wedge - Rev. 1 S-101-181806 2026-04-06 G817S111121605 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121605 2026-04-05 G817S111121606 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121606 2026-04-05 G817S111121607 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121607 2026-04-05 G817S111121608 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121608 2026-04-05 G817S111121610 SiNAPTIC Osteotomy Wedge System Cotton Wedge - Rev. 0 S-111-121610 2026-04-05
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