n/a

Basic Information

• Brand Name: n/a
• Primary DI: 05060267131836
• Version / Model: 102-1089
• Catalog Number: n/a
• Company Name: XIROS LTD
• Labeler DUNS: 228209805
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-08-12
• Public Version: 4
• Public Version Date: 2023-07-28
• Public Version Status: Update
• Public Device Record Key: e49a480f-5077-4e2f-946a-800ec6d3bbff

Device Description

Infinity-Lock Button System

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Conditional
• 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
HTN	Washer, Bolt Nut	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
62000	Acromioclavicular joint stabilization implant	A sterile implantable device intended to be used to approximate/stabilize the acromioclavicular joint to facilitate healing of a disrupted coracoclavicular ligament (i.e., the device is not intended to replace the damaged ligament). It is in the form of a cord with a loop for attachment to the coracoid process at one end, with a component for fixation to the clavicle (e.g., screw) at the other end. It may be implanted arthroscopically or during open surgery.	Yes	Active
61235	Cannulated surgical drill bit, single-use	A metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05060267131836	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K180243	000