78-50100

GUDID 07613327129304

PEEK CUSTOMIZED PRIORITY-CRANIOFACIAL

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate kit, non-bioabsorbable
Primary Device ID07613327129304
NIH Device Record Key5222ed6e-a69f-4f8a-b68c-d7bfdccc2c91
Commercial Distribution StatusIn Commercial Distribution
Version Model Number78-50100
Catalog Number78-50100
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327129304 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327129304]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-01
Device Publish Date2015-09-24

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37613327090827 - NA2026-02-18 Screws, increased head, Cross-Pin
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37613327090841 - NA2026-02-18 Screws, increased head, Cross-Pin
37613327090858 - NA2026-02-18 Bone Screws, square-fit, self-tapping
37613327090865 - NA2026-02-18 Bone Screws, square-fit, self-tapping
37613327090872 - NA2026-02-18 Bone Screws, square-fit, self-tapping
37613327090889 - NA2026-02-18 Bone Screws, square-fit, self-tapping

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