12-01542S

GUDID 07613327282344

2 HOLE PLATES W/TAB(3) SD SCREW(6) AXS

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate kit, non-bioabsorbable

• Primary Device ID: 07613327282344
• NIH Device Record Key: 83c12e65-7001-49cb-b36e-b5af9f533191
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 12-01542S
• Catalog Number: 12-01542S
• 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: 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327282344 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171152

FDA Product Code

• HBW: FASTENER, PLATE, CRANIOPLASTY

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: 2017-05-31

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

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• 07613327579888 - N/A: 2024-08-15 Tracking Instrument Battery
• 07613327635102 - NA: 2024-07-18 Neuro Dynamic Mesh L
• 07613327635119 - NA: 2024-07-18 Neuro Dynamic Mesh XL
• 07613327644074 - NA: 2024-07-03 Straight plate 34-hole
• 07613327300024 - NA: 2024-04-18
• 07613327556285 - NA: 2024-02-27 Facial iD MF 1 Mesh
• 07613327556308 - NA: 2024-02-23 Facial iD MF 2 meshes