ION Lumbar Tray

Basic Information

• Brand Name: ION Lumbar Tray
• Primary DI: 00810131882747
• Version / Model: SR12-7012
• Company Name: SURGENTEC, LLC
• Labeler DUNS: 004095409
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-09
• Public Version: 1
• Public Version Date: 2026-03-17
• Public Version Status: New
• Public Device Record Key: dc297eca-70af-463b-adb6-01e043bc487d

Device Description

SR12- ION Facet Screw System

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
MRW	System, Facet Screw Spinal Device	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
60792	Facet joint prosthesis	A sterile implantable device intended to resurface and/or replace a degenerative or otherwise diseased vertebral facet (apophyseal, zygapophyseal) joint. It typically consists of small plate-like metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr)] device intended to be fixed to the superior and inferior articulating surfaces of the joint. Fixation may be by means of a trans-laminar or trans-facet screw or bolt.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810131882747	GS1

Premarket Submissions

Submission Number	Supplement Number
K243265	000