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 General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit 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