CancelleX™ 13mm x 12mm x 12mm x 12* Cervical Interbody

GUDID B064XM3D31223121

XENCO MEDICAL LLC

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: B064XM3D31223121
• NIH Device Record Key: b12387d5-a0a9-40c2-b9e4-811f731335a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CancelleX™ 13mm x 12mm x 12mm x 12* Cervical Interbody
• Version Model Number: XM-3D-312-2312
• 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: 8582021505
• Email: sales@xencomedical.com
• Phone: 8582021505
• Email: sales@xencomedical.com
• Phone: 8582021505
• Email: sales@xencomedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B064XM3D31223121 [Primary]

FDA Product Code

• ODP: Intervertebral Fusion Device With Bone Graft, Cervical

Sterilization

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

[B064XM3D31223121]

Radiation Sterilization

[B064XM3D31223121]

Radiation Sterilization

[B064XM3D31223121]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-02-16
• Device Publish Date: 2026-02-06

Devices Manufactured by XENCO MEDICAL LLC

• B064XM3D31223121 - CancelleX™ 13mm x 12mm x 12mm x 12* Cervical Interbody: 2026-02-16
• B064XM3D31223121 - CancelleX™ 13mm x 12mm x 12mm x 12* Cervical Interbody: 2026-02-16
• B064XM3D31225061 - CancelleX™ 15mm x 13mm x 6mm x 12* Cervical Interbody: 2026-02-16
• B064XM3D31225071 - CancelleX™ 15mm x 13mm x 7mm x 12* Cervical Interbody: 2026-02-16
• B064XM3D31225081 - CancelleX™ 15mm x 13mm x 8mm x 12* Cervical Interbody: 2026-02-16
• B064XMPHCP610081 - 8mm One Level Cervical Plate: 2026-02-16
• B064HB11200101 - Tube Guard: 2023-08-15
• B064MPE010101 - Saratoga Cervical Brace: 2023-08-15
• B064MPE010401 - Tahiti Lumbar Brace: 2023-08-15