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FDA 510(k) & PMA Approved Devices — 42 products

Total Devices42
Categories15
Latest FDA decision2026-03-12
TypeNumberDevice NameCodeDateActions
510(k) K201047 Fusion Taper SystemLZO2021-04-16 View
510(k) K201278 World Hip Stem, World Cup, World LinerMEH2020-09-21 View
510(k) K191708 Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral HeadLPH2020-08-14 View
510(k) K192883 Spartan Hip StemLZO2020-08-05 View
510(k) K201951 Cemented Origin Hip StemLZO2020-07-31 View
510(k) K192024 Cemented TSI Hip StemLZO2020-06-19 View
510(k) K190577 World Knee Total Knee SystemsJWH2019-11-27 View
510(k) K190704 Signature Ceramic Femoral HeadLZO2019-08-28 View
510(k) K181340 Cemented TSI Hip StemJDI2019-02-11 View
510(k) K181338 Imboki Knee Instrument SystemJWH2019-01-17 View
510(k) K181190 Pinehurst Anterior Cervical Plate SystemKWQ2019-01-17 View
510(k) K180754 C-Zero Pedicle Screw System, Freedom Pedicle Screw SystemNKB2018-12-07 View
510(k) K181530 World Total Knee SystemJWH2018-10-24 View
510(k) K180750 World Knee SystemJWH2018-04-20 View
510(k) K163081 40-42mm BiPolar Head and 22mm Femoral HeadKWY2018-01-29 View
510(k) K172019 Brisbane ALIF Device, Gladstone ALIF DeviceOVD2017-11-29 View
510(k) K172020 Arlington PLIF/TLIF CageMAX2017-11-29 View
510(k) K163625 NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate SystemKWQ2017-08-11 View
510(k) K170613 Genius Total Knee SystemJWH2017-07-17 View
510(k) K160159 Active-X Total Knee SystemJWH2016-09-06 View

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