Streamline MIS Spinal Fixation System

GUDID 00840311246939

Spn Shrd Single Bevel Plm Hndl Jam Shidi

Xtant Medical Holdings, Inc.

General internal orthopaedic fixation system implantation kit

• Primary Device ID: 00840311246939
• NIH Device Record Key: b8f86107-065a-4f1a-b48a-e9699d2fa851
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Streamline MIS Spinal Fixation System
• Version Model Number: 724-263
• 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: true
• 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
• Phone: 1-888-886-9354
• Email: CS@xtantmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840311246939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K192396

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

[00840311246939]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-23
• Device Publish Date: 2024-05-15

On-Brand Devices [Streamline MIS Spinal Fixation System]

• 00840311246946: Spn Shrd Tri-Bevel Plm Hndl Jam Shidi
• 00840311246939: Spn Shrd Single Bevel Plm Hndl Jam Shidi