92-02325

GUDID 07613327682717

Pediatr. mandib. distractor 25mm right

Stryker Leibinger GmbH & Co. KG

Implantable craniofacial bone distractor

• Primary Device ID: 07613327682717
• NIH Device Record Key: 7a012584-279c-4117-b16f-1f3fb121b920
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 92-02325
• Catalog Number: 92-02325
• 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

• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter
• Height: 4.3 Millimeter
• Length: 57.8 Millimeter
• Device Size Text, specify: 0
• Width: 26.2 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327682717 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-09
• Device Publish Date: 2026-02-27

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 07613327682717 - NA: 2026-03-09Pediatr. mandib. distractor 25mm right
• 07613327682717 - NA: 2026-03-09 Pediatr. mandib. distractor 25mm right
• 07613327682724 - NA: 2026-03-09 Pediatr. mandib. distractor 25mm left
• 37613327090810 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090827 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090834 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090841 - NA: 2026-02-18 Screws, increased head, Cross-Pin
• 37613327090858 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping
• 37613327090865 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping