DTRAX Bone Screw

GUDID 20852776006021

The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture repair and fixation appropriate for the size of the device.

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Implantable cervical facet joint distractor

• Primary Device ID: 20852776006021
• NIH Device Record Key: 2e336266-a8ff-4d76-9ca0-f4ae8d9e1950
• Commercial Distribution Discontinuation: 2019-04-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DTRAX Bone Screw
• Version Model Number: PD-32-301
• 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	20852776006021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121713

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

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[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

[20852776006021]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-04-10
• Device Publish Date: 2015-09-15

On-Brand Devices [DTRAX Bone Screw]

• 10852776006024: The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct
• 20852776006024: The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct
• 20852776006021: The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruct