78-60100

GUDID 07613327300024

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable, non-customized

Primary Device ID	07613327300024
NIH Device Record Key	1b87bd9c-e7a6-4993-9f19-80829bc0140b
Commercial Distribution Status	In Commercial Distribution
Version Model Number	78-60100
Catalog Number	78-60100
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	false
Serial Number	false
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	07613327300024 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K153248

FDA Product Code

GWO	Plate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

[07613327300024]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2024-04-18
Device Publish Date	2024-04-10

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

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