78-50020

GUDID 07613327129281

PEEK Customized Cranial Implant Prio, M

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable

• Primary Device ID: 07613327129281
• NIH Device Record Key: a6a45253-c700-41e1-b97d-9a4794335a87
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-50020
• Catalog Number: 78-50020
• 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	07613327129281 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152076

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

Moist Heat or Steam Sterilization

[07613327129281]

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: 2015-09-24

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 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
• 07613252286622 - FLUOROMAP: 2025-02-05 FLUOROMAP 1.0 - ENABLE
• 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