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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K243469

SIGNEX · Osteonic Co., Ltd. · decided 2025-05-29 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
SignexL4A.35161OSTEONIC CO.,Ltd.HRS HWC08809595972264
SignexS1B.50650OSTEONIC CO.,Ltd.HRS HWC08809539698052
SignexG3F.35140OSTEONIC CO.,Ltd.HRS HWC08809539696560
SignexG3F.35090OSTEONIC CO.,Ltd.HRS HWC08809539696454
SignexL3A.35121OSTEONIC CO.,Ltd.HRS HWC08809595972578
SignexL4C.50180OSTEONIC CO.,Ltd.HRS HWC08809539699271
SignexG3E.35120OSTEONIC CO.,Ltd.HRS HWC08809539696409
SignexS1B.35450OSTEONIC CO.,Ltd.HRS HWC08809539694238
SignexJ2G.35061OSTEONIC CO.,Ltd.HRS HWC08800071049531
SignexG3E.50160OSTEONIC CO.,Ltd.HRS HWC08800071017721
SignexG3F.50070OSTEONIC CO.,Ltd.HRS HWC08809539698762
SignexG3F.35120OSTEONIC CO.,Ltd.HRS HWC08809539696553
SignexB2A.35071OSTEONIC CO.,Ltd.HRS HWC08800071049463
SignexB1D.25020OSTEONIC CO.,Ltd.HRS HWC08800071017790
SignexC7.24260OSTEONIC CO.,Ltd.HRS HWC08800071012887
SignexC6.35110OSTEONIC CO.,Ltd.HRS HWC08809595979003
SignexA1G.06060OSTEONIC CO.,Ltd.HRS HWC08809595977672
SignexL4A.35021OSTEONIC CO.,Ltd.HRS HWC08809595972387
SignexL4C.50120OSTEONIC CO.,Ltd.HRS HWC08809539699219
SignexK1E.50100OSTEONIC CO.,Ltd.HRS HWC08809539698571
SignexS1B.35240OSTEONIC CO.,Ltd.HRS HWC08809539694122
SignexC5.35180OSTEONIC CO.,Ltd.HRS HWC08809416068046
SignexB2A.35061OSTEONIC CO.,Ltd.HRS HWC08800071049456
SignexC7.24160OSTEONIC CO.,Ltd.HRS HWC08800071012832
SignexC7.37540OSTEONIC CO.,Ltd.HRS HWC08809595979287