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

Clearance record K112030

SYNTHES RADIAL HEAD PROSTHESIS SYSTEM · Synthes USA, LLC · decided 2012-06-19 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
(unnamed)03.402.719Synthes GmbHKWI10886982080271
(unnamed)04.402.030SSYNTHES (U.S.A.) LPKWI10886982128126
(unnamed)03.402.727SYNTHES (U.S.A.) LPKWI10886982080356
(unnamed)03.402.020SYNTHES (U.S.A.) LPKWI10886982079923
(unnamed)09.402.424SSYNTHES (U.S.A.) LPKWI10886982132727
(unnamed)03.402.626SYNTHES (U.S.A.) LPKWI10886982080189
(unnamed)03.402.722Synthes GmbHKWI10886982080301
(unnamed)03.402.010SYNTHES (U.S.A.) LPKWI10886982079909
(unnamed)03.402.009SYNTHES (U.S.A.) LPKWI10886982079893
(unnamed)03.402.728SYNTHES (U.S.A.) LPKWI10886982080363
(unnamed)09.402.022SSYNTHES (U.S.A.) LPKWI10886982132598
(unnamed)09.402.020SSYNTHES (U.S.A.) LPKWI10886982132581
(unnamed)09.402.428SSYNTHES (U.S.A.) LPKWI10886982132741
(unnamed)03.402.624SYNTHES (U.S.A.) LPKWI10886982080172
(unnamed)03.402.732SYNTHES (U.S.A.) LPKWI10886982080400
(unnamed)04.402.010SSYNTHES (U.S.A.) LPKWI10886982128072
(unnamed)03.402.024SYNTHES (U.S.A.) LPKWI10886982079947
(unnamed)04.402.006SSYNTHES (U.S.A.) LPKWI10886982128034
(unnamed)03.402.734SYNTHES (U.S.A.) LPKWI10886982080424
(unnamed)09.402.422SSYNTHES (U.S.A.) LPKWI10886982132710
(unnamed)03.402.718Synthes GmbHKWI10886982080264
(unnamed)03.402.007SYNTHES (U.S.A.) LPKWI10886982079879
(unnamed)03.402.622SYNTHES (U.S.A.) LPKWI10886982080165
(unnamed)03.402.022SYNTHES (U.S.A.) LPKWI10886982079930
(unnamed)09.402.028SSYNTHES (U.S.A.) LPKWI10886982132628