KeyLift™

Basic Information

• Brand Name: KeyLift™
• Primary DI: B1830712181100
• Version / Model: KeyLift™
• Catalog Number: 07-1218-110
• Company Name: FLOSPINE LLC
• Labeler DUNS: 042993143
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-03
• Public Version: 2
• Public Version Date: 2025-06-13
• Public Version Status: Update
• Public Device Record Key: d864d584-9d4b-453c-9572-14984ef7c795

Device Description

KeyLift XS 18mm Lg x 10mm H

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: Yes
• PM Exempt: No
• 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
PEK	Spinous Process Plate	Orthopedic	888.3050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61531	Lumbar decompression interspinous spacer	A device intended to be implanted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures, typically to treat a patient with symptomatic degenerative lumbar spinal stenosis (DLSS). It is typically designed as a small spacer, either a single-piece or assembly, made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and/or synthetic polymer [e.g., hydrogel, polyetheretherketone (PEEK)]. Disposable devices associated with implantation (e.g., introducer needles, trocars) may be included with the device.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B1830712181100	HIBCC

Customer Contacts

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

Device Sizes

Type	Value	Unit	Text
Length	18	Millimeter
Height	10	Millimeter