78-80030

GUDID 07613327300123

PEEK CUSTOMIZED PRIORITY-PLUS-L

Stryker Leibinger GmbH & Co. KG

Cranioplasty plate, non-alterable

• Primary Device ID: 07613327300123
• NIH Device Record Key: 7f3da154-bb20-4130-808e-1176d09ac584
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 78-80030
• Catalog Number: 78-80030
• 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	07613327300123 [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

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

Moist Heat or Steam Sterilization

[07613327300123]

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

• 07613327634945 - NA: 2024-10-01 Drill for 4/5mm screws SYK
• 07613327547429 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547436 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547443 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547450 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547467 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327547474 - DELTA: 2024-09-27 Delta wide-fit screwdriver blade
• 07613327616118 - N/A: 2024-08-30 Spine Guidance 5 Software