92-02332

GUDID 07613327504392

PEDIATRIC MANDIBULAR DISTRACTOR 2

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor

• Primary Device ID: 07613327504392
• NIH Device Record Key: a755059b-a70d-4e99-b37b-bd8ce7f9eff2
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-02332
• Catalog Number: 92-02332
• 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: 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

• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter
• Width: 15 Millimeter
• Length: 70 Millimeter
• Device Size Text, specify: 0
• Height: 5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327504392 [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: 2025-03-06
• Device Publish Date: 2020-05-12

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327579840 - N/A: 2025-09-16 Hybrid Tip Pointer
• 07613327680522 - NA: 2025-08-08 Locking plate
• 07613327651461 - NA: 2025-07-17 Burr hole cover with tab
• 07613327504385 - NA: 2025-03-06 PEDIATRIC MANDIBULAR DISTRACTOR 2
• 07613327504392 - NA: 2025-03-06PEDIATRIC MANDIBULAR DISTRACTOR 2
• 07613327504392 - NA: 2025-03-06 PEDIATRIC MANDIBULAR DISTRACTOR 2
• 07613327353563 - NA: 2025-02-27 NAVIGATED DRILL GUIDE SET CONTAINER
• 07613252196259 - FLUOROMAP: 2025-02-05 FLUOROMAP 1.0 - SALES DEMO CD
• 07613252286578 - FLUOROMAP: 2025-02-05 FLUOROMAP 1.0 SOFTWARE