Halo Systems

Basic Information

• Brand Name: Halo Systems
• Primary DI: 05690977192577
• Version / Model: 517DS
• Catalog Number: 517DS
• Company Name: OSSUR AMERICAS, INC.
• Labeler DUNS: 139280028
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-05-16
• Public Version: 4
• Public Version Date: 2023-09-18
• Public Version Status: Update
• Public Device Record Key: 30e4644c-b686-4432-88b9-2c410c9529ab
• Distribution End Date: 2020-02-28

Device Description

Skull Pin 3in CT Sterl 4 PK

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: MR Conditional
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: Yes
• Sterilization Methods: Ethylene Oxide

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LYT	FIXATION ACCESSORY	Orthopedic	888.3030	2

GMDN Terms

Code	Name	Definition	Implantable	Status
46664	Cervical spine immobilization head ring rod	An implantable, threaded rod that is a component of a cervical spine immobilization system (commonly known as a Halo vest) designed to secure the head ring to the skull of the patient by penetrating the outer bone of the skull at brow level. Commonly referred to as a pin, it is typically made of metal (e.g., stainless steel), may be ceramic-tipped, or made of non-ferromagnetic materials. It is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05690977192577	GS1

Premarket Submissions

Submission Number	Supplement Number
K040363	000