FDA.reportPublic FDA data

510(k) K243368

Device
Montblanc Plate System
Applicant
Medifield Medical Co., Ltd.
510(k) number
K243368
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2025-06-04
Date received
2024-10-30
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Bonggu Ha
Address
1st Floor, Bldg. A, 94-40, Yongjeong-Gyeongje-Ro 1-Gil, Gunnae-Myeon Pocheon-Si KR 11154 11154

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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