FDA.report

510(k) K180204

Device
CranioMaxillofacial Fixation (CMF) System - CMF Visionare
Applicant
Visionare LLC
510(k) number
K180204
Product code
JEY  
Decision
Substantially Equivalent (SESE)
Decision date
2018-12-28
Date received
2018-01-24
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

Related Records

Applicant Contact

Contact
Mariane de Oliveira Quinzani
Address
12251 Towne Lake Dr. Fort Myers FL US 33913 33913

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
00810004515116CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514829CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514836CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514843CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514850CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514867CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514874CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514881CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514898CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514904CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514911CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514928CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514935CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514942CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514959CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514966CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514973CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514980CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514997CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515000CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515024CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515031CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515048CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515055CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515062CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515079CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515086CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515093CMF VISIONAREVISIONARE, LLC2019-02-20
00810004515109CMF VISIONAREVISIONARE, LLC2019-02-20
00810004514621CMF VISIONAREVISIONARE, LLC2019-02-20

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
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
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

Legacy Summary

summary

FDA Review

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