Summa Orthopaedics Ankle Fibula Hook Plate System Bone Plate

GUDID 08806390868105

Jeil Medical Corporation

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 08806390868105
• NIH Device Record Key: 87bd5d39-e8e4-45c4-9901-4729dbccd979
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Summa Orthopaedics Ankle Fibula Hook Plate System Bone Plate
• Version Model Number: SO-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	08806390868105 [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

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

[08806390868105]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2024-06-04
• Device Publish Date: 2018-05-03

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

• 08806390868112: SO-35V-DLFH-004
• 08806390868105: SO-35V-DLFH-003