FDA.report

510(k) K240651

Device
MRI Universal
Applicant
Stryker Leibinger GmbH & Co KG
510(k) number
K240651
Product code
JEY
Decision
Substantially Equivalent (SESE)
Decision date
2024-07-12
Date received
2024-03-07
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
N

Related Records

Applicant Contact

Contact
Amelia Kesti
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)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
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
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