92-02322

GUDID 07613327504415

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor Implantable craniofacial bone distractor

• Primary Device ID: 07613327504415
• NIH Device Record Key: 41f4682c-a796-46e7-84b2-8e48bed8a62f
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-02322
• Catalog Number: 92-02322
• 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: false
• 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

• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Width: 15 Millimeter
• Length: 60 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327504415 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181504

FDA Product Code

• MQN: EXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-10-27
• Device Publish Date: 2020-05-12

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• 07613327556346 - NA: 2024-02-23 Facial iD MF 4 meshes
• 07613327556377 - NA: 2024-02-23 Facial iD MF 5 meshes
• 07613327556391 - NA: 2024-02-23 Facial iD MF 6 meshes
• 07613327556827 - NA: 2024-02-23 Facial iD MF 1 mesh kit