Anterolateral Tibia Plate 21311-15

GUDID 09120034309991

Anterolateral Tibia Plate, 15-Hole, Right

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034309991
• NIH Device Record Key: af63e93f-41a2-4cbd-a8dc-f0f5f27514f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Anterolateral Tibia Plate
• Version Model Number: 21311-15
• Catalog Number: 21311-15
• 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	09120034309991 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052011

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

[09120034309991]

Moist Heat or Steam Sterilization

Device Entry Metadata

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

On-Brand Devices [Anterolateral Tibia Plate]

• 09120047299814: Anterolateral Tibia Plate, 13-Hole, Left
• 09120047299807: Anterolateral Tibia Plate, 9-Hole, Left
• 09120047299791: Anterolateral Tibia Plate, 13-Hole, Right
• 09120047299784: Anterolateral Tibia Plate, 9-Hole, Right
• 09120047296844: Anterolateral Tibia Plate, 7-Hole, Left
• 09120047296837: Anterolateral Tibia Plate, 7-Hole, Right
• 09120047290064: Anterolateral Tibia Plate, 19-Hole, Left
• 09120047290057: Anterolateral Tibia Plate, 15-Hole, Left
• 09120047290040: Anterolateral Tibia Plate, 11-Hole, Left
• 09120047290019: Anterolateral Tibia Plate, 19-Hole, Right
• 09120034309991: Anterolateral Tibia Plate, 15-Hole, Right
• 09120034309984: Anterolateral Tibia Plate, 11-Hole, Right