605018S

GUDID 07613327350074

Cortex Screw S.T.

Stryker Trauma SA

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile

• Primary Device ID: 07613327350074
• NIH Device Record Key: c0c63b48-698c-4492-a052-97115e6773f2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 605018S
• Catalog Number: 605018S
• Company DUNS: 481999654
• Company Name: Stryker Trauma SA
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0
• Length: 18 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327350074 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162439

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-05

Devices Manufactured by Stryker Trauma SA

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• 07613327606027 - REUNION: 2024-08-30 Humeral 1 Express Insert
• 07613327606034 - REUNION: 2024-08-30 Humeral 2 Express Insert
• 07613327606041 - REUNION: 2024-08-30 Reverse Express Insert
• 07613327606058 - REUNION: 2024-08-30 Anatomic Express Insert
• 07613327606065 - REUNION: 2024-08-30 Anatomic Express Tray
• 07613327606072 - REUNION: 2024-08-30 Reverse Express Tray
• 07613327606089 - REUNION: 2024-08-30 Humeral 2 Express Tray