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510(k) K230733

Device
Stryker Resorbable Fixation System
Applicant
Stryker Leibinger GmbH & Co KG
510(k) number
K230733
Product code
JEY
Decision
Substantially Equivalent (SESE)
Decision date
2023-08-05
Date received
2023-03-16
Regulation
872.4760
Classification name
Plate, Bone
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Gregory Gohl
Address
Boetzinger Strasse 41 D-79111 Freiburg DE

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JEY#

510(k), Device, Applicant table
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K232889METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd.2024-04-30
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K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad2023-09-26
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K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.2022-11-10
K221855Universal CMF SystemStryker Leibinger GmbH & Co KG2022-11-09
K210731KLS Martin Individual Patient SolutionsKLS-Martin L.P.2022-07-18
K213777Stryker Resorbable Fixation SystemStryker Leibinger Micro Implants2022-02-04
K202969Biomet Microfixation OmniMax MMF SystemBiomet Microfixation2021-08-05