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

Clearance record K220959

OR3O Dual Mobility System · Smith & Nephew, Inc. · decided 2022-08-18 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
OR3O Dual Mobility71353372Smith & Nephew, Inc.LPH00885556800904
OR3O Dual Mobility71358253Smith & Nephew, Inc.LPH00885556800867
OR3O Dual Mobility71353373Smith & Nephew, Inc.LPH00885556800898
OR3O Dual Mobility71353315Smith & Nephew, Inc.LPH00885556710579
OR3O Dual Mobility71353371Smith & Nephew, Inc.LPH00885556800911
OR3O Dual Mobility71353317Smith & Nephew, Inc.LPH00885556710593
OR3O Dual Mobility71358254Smith & Nephew, Inc.LPH00885556800874
OR3O Dual Mobility71353374Smith & Nephew, Inc.LPH00885556800881