CORUS Spinal System-LX

Basic Information

• Brand Name: CORUS Spinal System-LX
• Primary DI: 00852776006584
• Version / Model: DX-22-500
• Company Name: Providence Medical Technology, Inc.
• Labeler DUNS: 969820245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-11-13
• Public Version: 1
• Public Version Date: 2024-11-21
• Public Version Status: New
• Public Device Record Key: d36188e3-04e2-41f9-9068-4825d89eb43f

Device Description

CORUS™ Spinal System-LX is a sterile-packaged set of instruments for joint access, bone preparation, implant delivery, and bone graft application indicated for posterior lumbar fusion in patients with lumbar degenerative disc disease

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
HRX	Arthroscope	Orthopedic	888.1100	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61300	Internal spinal fixation procedure kit, single-use	A collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852776006584	GS1

Premarket Submissions

Submission Number	Supplement Number
K212636	000