CAVUX Cage-LX, 4mm

GUDID 00852776006560

The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.

Providence Medical Technology, Inc.

Implantable cervical facet joint distractor

• Primary Device ID: 00852776006560
• NIH Device Record Key: ad74d5e4-6bba-4df1-ae8e-adc3de1b365d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAVUX Cage-LX, 4mm
• Version Model Number: PD-31-205
• 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	00852776006560 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K122801

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

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.

• 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
• 00852776006553 - ALLY Bone Screw-LX: 2024-11-21 The ALLY Bone Screw-LX is intended for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fr
• 00852776006560 - CAVUX Cage-LX, 4mm: 2024-11-21The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be used with autogenous bone graft and supplemental fixation, such as an anterior plating system.
• 00852776006560 - CAVUX Cage-LX, 4mm: 2024-11-21 The CAVUX Cage-LX is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine
• 00852776006584 - CORUS Spinal System-LX: 2024-11-21 CORUS™ Spinal System-LX is a sterile-packaged set of instruments for joint access, bone preparation, implant delivery, and bon
• 00852776006591 - CAVUX Facet Fixation System, 4mm: 2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX
• 00852776006607 - CAVUX Facet Fixation System, 5mm: 2024-11-21 CAVUX Facet Fixation System (CAVUX FFS) is an integrated construct comprised of a CAVUX Cage and a single ALLY Bone Screw. CAVUX
• 00852776006638 - CORUS Navigation Access System: 2024-11-21 The CORUS™ Navigation Access System-LX disposable instruments are used during the preparation and usage of CORUS™ Spinal Sys
• 00852776006492 - CAVUX Cervical Cage-X: 2024-11-01