Calix-C Cervical Interbody Spacer

GUDID M697C00300580

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

Xtant Medical Holdings, Inc.

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage 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

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

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

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