78-40100

GUDID 07613327129243

PEEK CUSTOMIZED-CRANIOFACIAL

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate kit, non-bioabsorbable

Primary Device ID	07613327129243
NIH Device Record Key	9bab27a2-734d-4604-975d-f1c2022e2da2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	78-40100
Catalog Number	78-40100
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	07613327129243 [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

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

[07613327129243]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	5
Public Version Date	2019-07-01
Device Publish Date	2015-09-24

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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