338612

GUDID 07613327080575

Cortex Screw S.T.

Stryker Trauma SA

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding) Orthopaedic bone screw (non-sliding)

• Primary Device ID: 07613327080575
• NIH Device Record Key: f2e7c4d3-b4d9-4556-8bc9-8e618de6eabf
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 338612
• Catalog Number: 338612
• 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

• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0
• Length: 12 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327080575 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050512

FDA Product Code

• HRS: PLATE, FIXATION, BONE

Sterilization

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

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

[07613327080575]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-05
• Device Publish Date: 2015-09-24

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