27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights

GUDID B064XM12789011

XENCO MEDICAL LLC

Orthopaedic implant/trial-implant/sizer holder, single-use

• Primary Device ID: B064XM12789011
• NIH Device Record Key: d4ed1f79-662d-4e3b-b809-aba79ed1fdcb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights
• Version Model Number: XM-127-8901
• Company DUNS: 079282130
• Company Name: XENCO MEDICAL LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com
• Phone: (858) 202-1505
• Email: sales@xencomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B064XM12789011 [Primary]

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

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

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

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[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

[B064XM12789011]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-04-06
• Device Publish Date: 2015-10-28

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• B064XM12789011 - 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights: 2020-04-06
• B064XM12789011 - 27mm x 12mm TLIF Trial Kit 8, 9, 10, 11 mm Heights: 2020-04-06
• B064XM12823451 - 28mm x 11mm Oblique Trials 12, 13, 14, 15 mm Heights: 2020-04-06 28mm x 11mm Oblique Trial Kit 12, 13, 14, 15 mm Heights