CORUS-LX Implant, 4mm

GUDID 00852776006478

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.

Providence Medical Technology, Inc.

Implantable cervical facet joint distractor

• Primary Device ID: 00852776006478
• NIH Device Record Key: b8910390-5073-42da-807d-afcab85c2800
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CORUS-LX Implant, 4mm
• Version Model Number: DX-50-407
• 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	00852776006478 [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: 2025-08-21The 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.
• 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