ARIX Ankle Fibula Hook Plate System Bone Plate

GUDID 08806390852005

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390852005
• NIH Device Record Key: 1eda47d6-da6d-404f-9818-d486d12a2948
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Ankle Fibula Hook Plate System Bone Plate
• Version Model Number: 35V-DLFH-003
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806390852005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170979

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

[08806390852005]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2024-06-06
• Device Publish Date: 2017-09-01

On-Brand Devices [ARIX Ankle Fibula Hook Plate System Bone Plate]

• 08806390852012: 35V-DLFH-004
• 08806390852005: 35V-DLFH-003