605050

GUDID 04546540388902

Cortex Screw S.T.

Stryker Trauma SA

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

• Primary Device ID: 04546540388902
• NIH Device Record Key: d215a8b4-5525-4877-9d48-ebe7b7fc80e3
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 605040
• Catalog Number: 605050
• 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: 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 Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540388902 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162439

FDA Product Code

• HRS: Plate, fixation, bone

Sterilization

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

[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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[04546540388902]

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Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-01-31
• Device Publish Date: 2017-04-05

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