CORUS-LX LevelOne, 4mm

GUDID 00852776006546

Three related devices: CORUS-LX Implant, CORUS Spinal System-LX and DiViNE Portal System-LX, referred to as “CORUS-LX LevelOne” – which represents a combination of these devices.

Providence Medical Technology, Inc.

Internal spinal fixation procedure kit, single-use

• Primary Device ID: 00852776006546
• NIH Device Record Key: 0a938232-e4d5-4989-9e27-9b0096897f9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORUS-LX LevelOne, 4mm
• Version Model Number: DX-50-409
• 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	00852776006546 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230840

FDA Product Code

• MRW: System, Facet Screw Spinal Device

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: 2025-08-21
• Device Publish Date: 2025-08-13

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 LevelOne” – which represents a combination of these devices.
• 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