Fibula Plate 3.5mm 21225-10

GUDID 09120047298329

Fibula Plate 3.5mm, 10-Hole, Right

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120047298329
• NIH Device Record Key: 610e126e-7634-4f47-95f8-0f87ffc88f97
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fibula Plate 3.5mm
• Version Model Number: 21225-10
• Catalog Number: 21225-10
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120047298329 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063672

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

[09120047298329]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-09-08

On-Brand Devices [Fibula Plate 3.5mm]

• 09120047298350: Fibula Plate 3.5mm, 12-Hole, Right
• 09120047298343: Fibula Plate 3.5mm, 12-Hole, Left
• 09120047298336: Fibula Plate 3.5mm, 10-Hole, Left
• 09120047298329: Fibula Plate 3.5mm, 10-Hole, Right
• 09120047298312: Fibula Plate 3.5mm, 8-Hole, Left
• 09120047298305: Fibula Plate 3.5mm, 8-Hole, Right
• 09120047298299: Fibula Plate 3.5mm, 6-Hole, Left
• 09120047298282: Fibula Plate 3.5mm, 6-Hole, Right
• 09120047298275: Fibula Plate 3.5mm, 4-Hole, Left
• 09120047298268: Fibula Plate 3.5mm, 4-Hole, Right