MIS Fusion Instruments

GUDID 00840311258048

T-Handle, Hudson

Xtant Medical Holdings, Inc.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: 00840311258048
• NIH Device Record Key: ec2f7e49-e4d5-4e28-80e1-5bb5121ad958
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MIS Fusion Instruments
• Version Model Number: 38-THANDLE
• Company DUNS: 081224143
• Company Name: Xtant Medical Holdings, 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: 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: 888-886-9354
• Email: cs@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311258048 [Primary]
GS1	00846468040673 [Previous]

FDA Product Code

• LXH: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

[00840311258048]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-10-03
• Device Publish Date: 2025-09-25

Devices Manufactured by Xtant Medical Holdings, Inc.

• 00840311258048 - MIS Fusion Instruments: 2025-10-03T-Handle, Hudson
• 00840311258048 - MIS Fusion Instruments: 2025-10-03 T-Handle, Hudson
• 00840311257942 - Streamline TL Spinal Fixation System: 2025-09-30 ROD TEMPLATE
• 00840311257935 - Streamline TL Spinal Fixation System: 2025-09-26 T-HANDLE, RATCHETING
• 00840311257867 - Cortera Spinal Fixation System: 2025-09-03 TAB SPLITTER, DOUBLE ACTION
• 00840311253494 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 11mm
• 00840311253500 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 15mm
• 00840311253517 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-OPEN, 5.5-6.0, 19mm
• 00840311253524 - Cortera Spinal Fixation System: 2025-08-29 CONNECTOR, R2R, OPEN-SIDE, 5.5-6.0, 11mm