CORUS Navigation Access System

GUDID 00852776006638

The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal System during spinal surgery to assist the surgeon in locating anatomical structures, such as the facet joint, in either open or minimally invasive procedures. The Navigation Access Chisel is specifically designed for use with Medtronic StealthStation™ for navigation of the instrument to the facet joint. The instrument set provides access to the posterior spinal facet joint and a decortication for bone preparation.

Providence Medical Technology, Inc.

Internal spinal fixation procedure kit, single-use

• Primary Device ID: 00852776006638
• NIH Device Record Key: 0abf6e04-5f82-4396-b0ab-9bde27901ecf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORUS Navigation Access System
• Version Model Number: DX-01-160
• Company DUNS: 969820245
• Company Name: Providence Medical Technology, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852776006638 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240625

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-21
• Device Publish Date: 2024-11-13

Devices Manufactured by Providence Medical Technology, Inc.

• 00852776006478 - CORUS-LX Implant, 4mm: 2025-08-21 The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant.
• 00852776006539 - CORUS-LX Implant, 5mm: 2025-08-21 The CAVUX Cage-LX is used in conjunction with ALLY Bone ScrewLX as an integrated construct referred to as the CORUS-LX Implant
• 00852776006546 - CORUS-LX LevelOne, 4mm: 2025-08-21 Three related devices: CORUS-LX Implant, CORUS Spinal System-LX and DiViNE Portal System-LX, referred to as “CORUS-LX LevelO
• 00852776006577 - CAVUX Cage-LX, 5mm: 2025-07-16 The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine
• 00852776006645 - CORUS PCSS Implant 4mm: 2025-02-27 CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabiliz
• 00852776006676 - CORUS PCSS Implant, 5mm: 2025-02-27 CORUS™ PCSS is posterior spinal instrumentation with integrated screw fixation intended to provide immobilization and stabiliz
• 00852776006683 - CORUS PCSS LevelOne, 4mm: 2025-02-27 Three related devices: CORUS PCSS Implant, CORUS Spinal System and DiViNE Portal System, referred to as “CORUS™ PCSS LevelO
• 00852776006447 - CAVUX CERVICAL CAGE-X, 5MM: 2024-11-21 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac