605026S

GUDID 07613327350029

Cortex Screw S.T.

Stryker Trauma SA

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

• Primary Device ID: 07613327350029
• NIH Device Record Key: 8df6a607-67c7-4535-a621-a518e74135af
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 605026S
• Catalog Number: 605026S
• 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

• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter
• Device Size Text, specify: 0
• Length: 26 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327350029 [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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• 07613327614633 - PANGEA: 2024-12-09 Tap, Locking, AO
• 07613327624786 - PANGEA: 2024-12-09 Drill Bit, MIS, AO
• 07613327624809 - PANGEA: 2024-12-09 Tissue Protection Sleeve, MIS
• 07613327624816 - PANGEA: 2024-12-09 Variable Angle Drill Guide, MIS
• 07613327624830 - PANGEA: 2024-12-09 Aiming Block Distal Lateral Femur MIS, L
• 07613327624847 - PANGEA: 2024-12-09 Plate Hole Marker, MIS