52-20358

GUDID 34546540227608

BONE SCREWS, CROSS-FIT, SELF-TAPPING

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile

• Primary Device ID: 34546540227608
• NIH Device Record Key: 7c93fab2-1f1e-40fb-ba6f-6f81ad9ad001
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 52-20358
• Catalog Number: 52-20358
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 4
• 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: 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

• Device Size Text, specify: 0
• Length: 8 Millimeter
• Device Size Text, specify: 0
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Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540227607 [Unit of Use]
GS1	34546540227608 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K963030

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

[34546540227608]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-06-16

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• 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