Quantum Spinal Fixation System

Basic Information

• Brand Name: Quantum Spinal Fixation System
• Primary DI: 00191083025469
• Version / Model: 721-837
• Catalog Number: 721-837
• Company Name: Rti Surgical, Inc.
• Labeler DUNS: 117560455
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-09-25
• Public Version: 5
• Public Version Date: 2023-10-19
• Public Version Status: Update
• Public Device Record Key: 33abf00d-950f-4299-9e65-6ed1ffe66715

Device Description

QSRS, Big Ugly Compressor

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• 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: Yes
• 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
HWN	INSTRUMENT, COMPRESSION	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47870	Orthopaedic fixation implant alignment tool	A surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00191083025469	GS1

Customer Contacts

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