Cortium Universal OCT Spinal Fixation System

Basic Information

• Brand Name: Cortium Universal OCT Spinal Fixation System
• Primary DI: 00814386028844
• Version / Model: UU072-14-0104
• Company Name: Ulrich Medical Usa, Inc.
• Labeler DUNS: 624083866
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-19
• Public Version: 2
• Public Version Date: 2024-06-20
• Public Version Status: Update
• Public Device Record Key: 516a5cb2-899d-4a4f-94e3-cefefa37b121

Device Description

Palm handle, torque limiting, 3.0Nm., 1/4" square

Device Characteristics

• Single Use: No
• 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: 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
NKG	Posterior Cervical Screw System	Orthopedic	888.3075	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32871	Surgical torque wrench, reusable	A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00814386028844	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K230614	000