Calix-C Cervical Interbody Spacer

GUDID M697C00300580

SPECIAL LORDOTIC RASP, 11mm x 14mm x 5mm

Xtant Medical Holdings, Inc.

Polymeric spinal interbody fusion cage

• Primary Device ID: M697C00300580
• NIH Device Record Key: 63ae5dc3-6830-4d39-a2aa-2c4f0130b3f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calix-C Cervical Interbody Spacer
• Version Model Number: C003-0058
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, Inc.
• 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: 888-886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com
• Phone: +1(888)886-9354
• Email: CS@xtantmedical.com

Device Dimensions

• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree
• Height: 5 Millimeter
• Angle: 7 degree

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C00300580 [Direct Marking]
HIBCC	M697C00300581 [Primary]

FDA Product Code

• HTR: Rasp

Sterilization

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

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

[M697C00300580]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-25
• Device Publish Date: 2022-08-17

On-Brand Devices [Calix-C Cervical Interbody Spacer]

• M697C00300570: Special 13mm x 16mm Lordotic Rasp, 12mm
• M697C00300560: Special 13mm x 16mm Lordotic Rasp, 11mm
• M697C00300550: Special 13mm x 16mm Lordotic Rasp, 10mm
• M697C00300540: Special 13mm x 16mm Lordotic Rasp, 9mm
• M697C00300530: Special 13mm x 16mm Lordotic Rasp, 8mm
• M697C00300520: Special 13mm x 16mm Lordotic Rasp, 7mm
• M697C00300510: Special 13mm x 16mm Lordotic Rasp, 6mm
• M697C00300590: SPECIAL LORDOTIC RASP, 11mm x 14mm x 6mm
• M697C00300580: SPECIAL LORDOTIC RASP, 11mm x 14mm x 5mm
• M697C00300600: SPECIAL LORDOTIC RASP, 11mm x 14mm x 7mm