78-10020

GUDID 07613327004021

PEEK CUSTOMIZED CRANIAL IMPLANT KIT, M

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable Cranioplasty plate, non-alterable

• Primary Device ID: 07613327004021
• NIH Device Record Key: 5b199104-1af5-4d17-a022-86534a9bdb8e
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-10020
• Catalog Number: 78-10020
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327004021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121153

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

[07613327004021]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-07-03

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 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
• 07613327556322 - NA: 2024-02-23 Facial iD MF 3 meshes
• 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