CORUS™ Spinal System

Basic Information

• Brand Name: CORUS™ Spinal System
• Primary DI: 00852776006430
• Version / Model: DX-22-100
• Company Name: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Labeler DUNS: 969820245
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-23
• Public Version: 1
• Public Version Date: 2019-07-31
• Public Version Status: New
• Public Device Record Key: 8d0bd47c-a088-40cb-a6da-910b2b4fd800

Device Description

The CORUS Spinal System instruments are used to access and prepare the posterior cervical spine for joint fusion by decortication of bone surfaces, including the posterior lateral mass and facet joints, combined with application of allograft or autograft in patients with or without anterior or posterior instrumentation. It is recommended that commercially available autograft or allograft be used to aid fusion. Autograft or allograft material is not supplied as part of the 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: 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
32579	Spinal endoscopic-access system	An assembly of devices used to gain access to the spine by dilation of the overlying tissues for the placement and support of an endoscope. It typically includes the endoscope, a light source, a fibreoptic light cable, a camera control unit, a camera, and cannulae (portals). It is used for posterior or anterior access and visualization of a surgical area of the cervical, thoracic, or lumbar spine, allowing the surgeon to perform a procedure such as, a discectomy, nucleotomy, spinal fusion, spinal decompression, foraminotomy, or insertion of spinal implants. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00852776006430	GS1
Package	10852776006437	GS1		1	In Commercial Distribution

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K190201	000