Taurus Pedicle Screw System

Basic Information

• Brand Name: Taurus Pedicle Screw System
• Primary DI: M555503000011
• Version / Model: X
• Catalog Number: 50-3000-011
• Company Name: SINTX Technologies, Inc.
• Labeler DUNS: 028629553
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-04-27
• Public Version: 8
• Public Version Date: 2026-03-20
• Public Version Status: Update
• Public Device Record Key: 10d7eabc-86d3-425e-9c78-e80f4a349c43
• Distribution End Date: 2023-09-14

Device Description

Driver, Polyaxial, 11in

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LHX	Trousers, Anti-Shock	Cardiovascular	870.5800	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64192	Internal spinal fixation procedure kit, reusable	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M555503000011	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	11	Inch