FDA.reportPublic FDA data

510(k) K221855

Device
Universal CMF System
Applicant
Stryker Leibinger GmbH & Co. KG
510(k) number
K221855
Product code
JEY  
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-09
Date received
2022-06-27
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
Amelia Kesti
Address
Boetzinger Strasse 41 Freiburg DE D-79111 D-79111

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JEY  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252246Leforte MMF SystemJeil Medical Corporation2026-04-02
K253373Southern Craniomaxillofacial (CMF) SystemSouthern Medical (Pty) , Ltd.2025-12-19
K251441Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation SystemInion OY2025-11-07
K241314KLS Martin Oral-Max Implants MR Conditional (bundled)KLS-Martin L.P.2024-08-16
K240651MRI UniversalStryker Leibinger GmbH & Co KG2024-07-12
K233874tmCMF SolutionTechmah Cmf2024-07-11
K232889METICULY Patient-specific titanium maxillofacial mesh implantMeticuly Co., Ltd.2024-04-30
K232350Stryker Facial iD SystemStryker Craniomaxillofacial2024-01-13
K230398MedCAD® AccuPlate® 3DTi Patient-Specific Plating SystemMedcad2023-09-26
K230733Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KG2023-08-05
K222650Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon PlateStryker Craniomaxillofacial (Cmf)2022-12-09
K220360Tandry CMF Plate SystemMicroware Precision Co., Ltd.2022-11-10
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

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases