Lumbar Interbody Fusion System (OLLIF)

Basic Information

• Brand Name: Lumbar Interbody Fusion System (OLLIF)
• Primary DI: 00850014575779
• Version / Model: 01-9080-18U
• Catalog Number: 01-9080-18U
• Company Name: ADVANCED RESEARCH MEDICAL LLC
• Labeler DUNS: 117201206
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-08-12
• Public Version: 2
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: e345c9d8-b551-44c5-b648-89b7569f5961

Device Description

Lumbar Interbody Fusion System (OLLIF) Guide Wire - 1.4 mm X 18 in [Unthreaded]

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: Yes
• 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
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	888.3080	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35685	Orthopaedic bone wire	A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	10850014575776	GS1		10	In Commercial Distribution
Primary	00850014575779	GS1
Package	20850014575773	GS1		25	In Commercial Distribution
Package	30850014575770	GS1		100	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K173947	000

Device Sizes

Type	Value	Unit	Text
Guidewire Diameter	1.4	Millimeter
Length	18	Inch