78-80010

GUDID 07613327300048

PEEK Customized PRIORITY-PLUS-S

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable

• Primary Device ID: 07613327300048
• NIH Device Record Key: dd593409-295b-439e-8596-f5fe6a69b2ae
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-80010
• Catalog Number: 78-80010
• Company DUNS: 316153956
• Company Name: Stryker Leibinger GmbH & Co. KG
• Device Count: 1
• DM Exempt: true
• 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: false
• Serial Number: true
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	07613327300048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152076
• Premarket Notification: K153248

FDA Product Code

• GWO: Plate, cranioplasty, preformed, alterable

Sterilization

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

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

[07613327300048]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-02-04
• Device Publish Date: 2021-01-27

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 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
• 37613327090872 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping
• 37613327090889 - NA: 2026-02-18 Bone Screws, square-fit, self-tapping