Streamline® MIS Spinal Fixation System

GUDID 00840311245413

Streamline MIS, Cannulated Tap, Ø5.5mm

Xtant Medical Holdings, Inc.

Bone tap, reusable

• Primary Device ID: 00840311245413
• NIH Device Record Key: cb8549fa-2125-4fff-ba93-80760360ac9c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline® MIS Spinal Fixation System
• Version Model Number: 04-CANNTAP-55
• 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: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com
• Phone: 18888869354
• Email: cs@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311245413 [Primary]

FDA Product Code

• HWX: Tap, Bone

Sterilization

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

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

[00840311245413]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-01-23
• Device Publish Date: 2025-01-15

Devices Manufactured by Xtant Medical Holdings, Inc.

• 00840311245413 - Streamline® MIS Spinal Fixation System: 2025-01-23Streamline MIS, Cannulated Tap, Ø5.5mm
• 00840311245413 - Streamline® MIS Spinal Fixation System: 2025-01-23 Streamline MIS, Cannulated Tap, Ø5.5mm
• M697T09402001 - Atrix-C Cervical Allograft Spacer: 2024-11-25 Cortical Inserter Tip
• M697X09400071 - Atrix-C Cervical Allograft Spacer: 2024-11-25 SOFT CARRY CASE II, ATRIX-C SPACERS
• M697X09400231 - Atrix-C Cervical Allograft Spacer: 2024-11-25 ATRIX-C CORTICAL/CANCELLOUS IMPLANT SOFT CARRY CASE
• 00840311207435 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x25
• 00840311207442 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x30
• 00840311207459 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x35
• 00840311207466 - Cortera Spinal Fixation System: 2024-10-17 Rod, Ti, Prebent, 6.0x40