CORUS-LX Implant, 4mm

Basic Information

• Brand Name: CORUS-LX Implant, 4mm
• Primary DI: 00852776006478
• Version / Model: DX-50-407
• Company Name: Providence Medical Technology, Inc.
• Labeler DUNS: 969820245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-08-13
• Public Version: 1
• Public Version Date: 2025-08-21
• Public Version Status: New
• Public Device Record Key: b8910390-5073-42da-807d-afcab85c2800

Device Description

The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant. The device achieves facet fixation by spanning the facet interspace with points of fixation at each end of the construct. The device provides rigid fixation as an adjunct to fusion with the bone screw providing additional anchoring into cortical bone. The titanium constructs are offered in various footprints and heights and are manufactured from implant grade titanium alloy (6Al-4V Ti). CORUS-LX Implant is single-use only, provided sterile (gamma sterilized) with pre-attached, disposable, delivery handles. CORUSLX Implant should be implanted only using the CORUS™ Spinal System-LX.

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: 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
MRW	System, Facet Screw Spinal Device	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58109	Implantable cervical facet joint distractor	A non-powered wedge-shaped device intended to be inserted within a cervical facet joint (spinal joint), i.e., intra-facet, for joint distraction; the distraction is intended to facilitate nerve root decompression and stabilization of the spine in the treatment of various spinal conditions. It is typically fenestrated or barbed and may incorporate a screw to expand to shape and/or to provide fixation within the joint and cervical spine stabilization. It typically includes single-use instruments (e.g., chisels, rasps) for implantation.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852776006478	GS1

Premarket Submissions

Submission Number	Supplement Number
K230840	000