22-23410

GUDID 37613154156208

BONE SCREWS,CROSS-PIN,SELF-TAPPING

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile

• Primary Device ID: 37613154156208
• NIH Device Record Key: d73e5882-a45f-4b6b-89e0-db9a949964b6
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 22-23410
• Catalog Number: 22-23410
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 2
• 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: true
• 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: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
• Length: 10 Millimeter
• Device Size Text, specify: 0
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• Device Size Text, specify: 0
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• Device Size Text, specify: 0
• Length: 10 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613154156207 [Unit of Use]
GS1	37613154156208 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K014263

FDA Product Code

• JEY: PLATE, 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: 2015-07-07

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 37613327090810 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090827 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090834 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090841 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090858 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping
• 37613327090865 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping
• 37613327090872 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping
• 37613327090889 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping