92-02322

GUDID 07613327504415

Stryker Leibinger GmbH & Co. KG

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

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327401523 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401554 - NA: 2025-01-17 SternalPlate, T
• 07613327401561 - NA: 2025-01-17 SternalPlate, Transverse, w/ bars
• 07613327401738 - NA: 2025-01-17 SternalPlate, T
• 07613327634952 - NA: 2024-12-16 Drill for 6514-7-200 WL 16mm
• 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