DTRAX Cervical Cage-B

GUDID 20852776006069

The DTRAX Cervical Cage-B 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.

Implantable cervical facet joint distractor

• Primary Device ID: 20852776006069
• NIH Device Record Key: 77b230fd-78dd-437d-bef1-88fd04d44544
• Commercial Distribution Discontinuation: 2019-04-09
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: DTRAX Cervical Cage-B
• Version Model Number: PD-31-200
• 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	20852776006069 [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

[20852776006069]

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 Cervical Cage-B]

• 10852776006000: The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in va
• 20852776006000: The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in va
• 20852776006069: The DTRAX Cervical Cage-B is a single-use, titanium alloy intervertebral implant available in va