51-17108

GUDID 04546540435590

BONE ANCHOR SCREWS,SELF-TAPPING

Stryker Leibinger GmbH & Co. KG

Craniofacial bone screw, non-bioabsorbable, sterile

• Primary Device ID: 04546540435590
• NIH Device Record Key: 142ddda4-c7ea-4b5d-94ef-05d35c77a85a
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 51-17108
• Catalog Number: 51-17108
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540435590 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041651

FDA Product Code

• DZE: IMPLANT, ENDOSSEOUS, ROOT-FORM

Sterilization

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

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

Moist Heat or Steam Sterilization

[04546540435590]

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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• 07613327634990 - NA: 2024-12-16 Drill for 6514-7-200 14mm
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• 07613327635010 - NA: 2024-12-16 Drill for 6514-7-200 WL 14mm
• 07613327651058 - NA: 2024-11-20 T-plate malleable left