CAVUX Cervical Cage-T PD-31-100

GUDID 00852776006010

The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 00852776006010
• NIH Device Record Key: 91864f13-7168-4db4-a8b2-5ec314ee9a09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CAVUX Cervical Cage-T
• Version Model Number: PD-31-100
• Catalog Number: PD-31-100
• Company DUNS: 969820245
• Company Name: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• 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	00852776006010 [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: true
• Device Is Sterile: true

[00852776006010]

Radiation Sterilization

[00852776006010]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2020-02-24
• Device Publish Date: 2015-09-02

Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.

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• 00852776006423 - CAVUX™ Cervical Cage SB: 2020-02-24 CAVUX® Cervical Cages are titanium constructs offered in various footprints and heights. All CAVUX® Cervical Cages are manufac
• 00852776006003 - CAVUX Cervical Cage-B: 2020-02-24 The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It
• 00852776006010 - CAVUX Cervical Cage-T: 2020-02-24The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be used in cervical spinal fusion surgery for skeletally mature patients with degenerative disc disease of the cervical spine with accompanying radicular symptoms at one disc level.
• 00852776006010 - CAVUX Cervical Cage-T: 2020-02-24 The CAVUX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It
• 10852776006277 - CAVUX™ Cervical Cage-L 8x12x15mm 7 deg: 2020-02-24 CAVUXTM Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical sp
• 10852776006321 - CAVUX™ Cervical Cage-B 5mm: 2020-02-24 CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spin