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

Clearance record K191002

OR3O Dual Mobility System · Smith & Nephew, Inc. · decided 2019-10-31 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
OR3O Dual Mobility71353323Smith & Nephew, Inc.LPH00885556710647
OR3O Dual Mobility71358207Smith & Nephew, Inc.LPH00885556712283
OR3O Dual Mobility71353307Smith & Nephew, Inc.LPH00885556710500
OR3O Dual Mobility71353324Smith & Nephew, Inc.LPH00885556710654
OR3O Dual Mobility71358221Smith & Nephew, Inc.LPH00885556712399
OR3O Dual Mobility71358208Smith & Nephew, Inc.LPH00885556712290
OR3O Dual Mobility71353318Smith & Nephew, Inc.LPH00885556710609
OR3O Dual Mobility71353303Smith & Nephew, Inc.LPH00885556710463
OR3O Dual Mobility71353301Smith & Nephew, Inc.LPH00885556710449
OR3O Dual Mobility71358218Smith & Nephew, Inc.LPH00885556712375
OR3O Dual Mobility71358224Smith & Nephew, Inc.LPH00885556712429
OR3O Dual Mobility71358211Smith & Nephew, Inc.LPH00885556712313
OR3O Dual Mobility71358205Smith & Nephew, Inc.LPH00885556712269
OR3O Dual Mobility71353314Smith & Nephew, Inc.LPH00885556710562
OR3O Dual Mobility71358206Smith & Nephew, Inc.LPH00885556712276
OR3O Dual Mobility71353302Smith & Nephew, Inc.LPH00885556710456
OR3O Dual Mobility71358216Smith & Nephew, Inc.LPH00885556712351
OR3O Dual Mobility71353325Smith & Nephew, Inc.LPH00885556710661
OR3O Dual Mobility71353316Smith & Nephew, Inc.LPH00885556710586
OR3O Dual Mobility71358209Smith & Nephew, Inc.LPH00885556712306
OR3O Dual Mobility71353309Smith & Nephew, Inc.LPH00885556710524
OR3O Dual Mobility71353311Smith & Nephew, Inc.LPH00885556710531
OR3O Dual Mobility71358222Smith & Nephew, Inc.LPH00885556712405
OR3O Dual Mobility71353305Smith & Nephew, Inc.LPH00885556710487
OR3O Dual Mobility71358204Smith & Nephew, Inc.LPH00885556712252