Six Fix Circular Fixation System 641018400

GUDID 00850030203939

Smooth Wire 1.8x400mm

Amdt Holdings, Inc.

External orthopaedic fixation system, single-use

• Primary Device ID: 00850030203939
• NIH Device Record Key: 6f96801e-2276-4c02-bc15-c8ab26c474d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Six Fix Circular Fixation System
• Version Model Number: 1
• Catalog Number: 641018400
• Company DUNS: 117990191
• Company Name: Amdt 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: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com
• Phone: 19018534366
• Email: INFO@amdtholdings.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850030203939 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190069

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

[00850030203939]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-14
• Device Publish Date: 2023-08-04

On-Brand Devices [Six Fix Circular Fixation System]

• 00850030203960: Olive Wire 1.8x400mm
• 00850030203953: Smooth Wire 2.0x400mm
• 00850030203946: Olive Wire 2.0x450mm
• 00850030203939: Smooth Wire 1.8x400mm