FDA.report

510(k) K232350

Device
Stryker Facial iD System
Applicant
Stryker Craniomaxillofacial
510(k) number
K232350
Product code
JEY
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-13
Date received
2023-08-07
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
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Jonathan Schell
Address
1941 Stryker Way Portage MI US 49002 49002

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code JEY

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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
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