DTRAX Bone Screw PD-32-301

GUDID 10852776006024

The DTRAX Bone Screw is a single-use implant made of titanium alloy and used in bone reconstruction, osteotomy, arthrodesis, join fusion, fracture rep

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Implantable cervical facet joint distractor

• Primary Device ID: 10852776006024
• NIH Device Record Key: 808faf7b-31be-44e3-9ed9-d7749ab08131
• Commercial Distribution Discontinuation: 2019-03-28
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DTRAX Bone Screw
• Version Model Number: PD-32-301
• Catalog 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	10852776006024 [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

[10852776006024]

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

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