FDA.report

510(k) K232889

Device
METICULY Patient-specific titanium maxillofacial mesh implant
Applicant
Meticuly Co., Ltd.
510(k) number
K232889
Product code
JEY
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-30
Date received
2023-09-18
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
Peeranoot Lohwongwatana
Address
924 B Bldg., Rm. B116-118, B210-212 Soi Chula 7, Wang Mai, Pathum Wan Bangkok TH 10330 10330

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
18859751213141METICULY Patient-specific titanium maxillofacial mesh implantMETICULY COMPANY LIMITED2024-07-31
18859751213134METICULY Patient-specific titanium maxillofacial mesh implantMETICULY COMPANY LIMITED2024-07-31
18859751213127METICULY Patient-specific titanium maxillofacial mesh implantMETICULY COMPANY LIMITED2024-07-31
18859751213110METICULY Patient-specific titanium maxillofacial mesh implantMETICULY COMPANY LIMITED2024-07-31
18859751212120METICULY Patient-specific titanium maxillofacial mesh implantMETICULY COMPANY LIMITED2024-07-31
18859751212113METICULY Patient-specific titanium maxillofacial mesh implantMETICULY COMPANY LIMITED2024-07-31

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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
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