56-90616S

GUDID 07613327382549

1.5/1.7MM DYNAMIC MESH-STD-LARGE-S

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

• Primary Device ID: 07613327382549
• NIH Device Record Key: b78fa8f1-8acb-4a25-98c8-7891ff250c25
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 56-90616S
• Catalog Number: 56-90616S
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: 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: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter
• Device Size Text, specify: 0
• Length: 120 Millimeter
• Width: 120 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327382549 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182425

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-20
• Device Publish Date: 2018-11-19

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

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• 07613327634969 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634976 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634990 - NA: 2024-12-16 Drill for 6514-7-200 14mm
• 07613327635003 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327635010 - NA: 2024-12-16 Drill for 6514-7-200 WL 14mm
• 07613327651058 - NA: 2024-11-20 T-plate malleable left