Cortex Screw, 3.5mm x 48mm, T15, Flex-Thread™

Basic Information

• Brand Name: Cortex Screw, 3.5mm x 48mm, T15, Flex-Thread™
• Primary DI: 00840118117296
• Version / Model: 8428-48-S
• Company Name: FLOWER ORTHOPEDICS CORPORATION
• Labeler DUNS: 078790947
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-03-19
• Public Version: 2
• Public Version Date: 2024-02-12
• Public Version Status: Update
• Public Device Record Key: eb8a64fa-0cd6-44d0-94b6-c12511c65786

Device Description

Intramedullary fixation rod and accessories

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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HSB	ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES	Orthopedic	888.3020	2

GMDN Terms

Code	Name	Definition	Implantable	Status
44759	General internal orthopaedic fixation system implantation kit	A collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is 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	00840118117296	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Outer Diameter	3.5	Millimeter
Length	48	Millimeter