DTRAX Cervical Cage-T PD-31-100

GUDID 10852776006017

The DTRAX Cervical Cage-T is a single-use, titanium alloy intervertebral implant available in various footprints and heights. It is intended to be use

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Implantable cervical facet joint distractor

• Primary Device ID: 10852776006017
• NIH Device Record Key: 2952b274-3a55-4a98-9e88-e47fcf0a4bba
• Commercial Distribution Discontinuation: 2019-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DTRAX 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	10852776006017 [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

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

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[10852776006017]

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[10852776006017]

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[10852776006017]

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[10852776006017]

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[10852776006017]

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[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

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[10852776006017]

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[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

[10852776006017]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-03-29
• Device Publish Date: 2015-09-03

Devices Manufactured by PROVIDENCE MEDICAL TECHNOLOGY, INC.

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• 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: 2024-11-21 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