Calix P

GUDID M697C03402490

Calix P Specialty Slap Hammer

X-SPINE SYSTEMS, INC.

Polymeric spinal interbody fusion cage

• Primary Device ID: M697C03402490
• NIH Device Record Key: 856ab972-377f-44d8-9386-a7023c303685
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calix P
• Version Model Number: C034-0249
• Company DUNS: 610042587
• Company Name: X-SPINE SYSTEMS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: +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 Identifiers

Device Issuing Agency	Device ID
HIBCC	M697C03402490 [Direct Marking]
HIBCC	M697C03402491 [Primary]

FDA Product Code

• HXL: Mallet

Sterilization

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

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

[M697C03402490]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-02-24
• Device Publish Date: 2018-05-18

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• 00889795113238 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 1.0cc
• 00889795113245 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 2.5cc
• 00889795113252 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 5.0cc
• 00889795113269 - BEAST Injectable Putty: 2021-05-27 BEAST Injectable Putty, 10cc