78-70040

GUDID 07613327300031

PEEK CUSTOMIZED-PLUS-XL

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable

• Primary Device ID: 07613327300031
• NIH Device Record Key: d2df3aee-fa83-4b56-a36c-8181796a0948
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-70040
• Catalog Number: 78-70040
• 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	07613327300031 [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

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

[07613327300031]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-07-01
• Device Publish Date: 2017-02-21

Devices Manufactured by Stryker Leibinger GmbH & Co. KG

• 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
• 07613327634952 - NA: 2024-12-16 Drill for 6514-7-200 WL 16mm
• 07613327634969 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm
• 07613327634976 - NA: 2024-12-16 Drill for 6514-7-200 WL 10mm
• 07613327634983 - NA: 2024-12-16 Drill for 6514-7-200 WL 12mm