Ti6® Internal Fixation System

Basic Information

• Brand Name: Ti6® Internal Fixation System
• Primary DI: 10381780245094
• Version / Model: FS2085
• Catalog Number: FS2085
• Company Name: Ascension Orthopedics, Inc.
• Labeler DUNS: 942377524
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-09-05
• Public Version: 5
• Public Version Date: 2023-01-25
• Public Version Status: Update
• Public Device Record Key: 63bcb231-32d9-42be-bc4f-8c61b6f13962
• Distribution End Date: 2026-12-31

Device Description

Integra® Ti6® The Ti6 CounterSink is used to add space or clearance for the head of a TS-Series 3.0 or 4.0mm screw with AO.

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: 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
HXX	SCREWDRIVER	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
33968	Surgical screwdriver, reusable	A non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Secondary	M269FS20851	HIBCC
Primary	10381780245094	GS1

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Large; 3.865 in L