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Kalitec Direct, LLC

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories4
Latest FDA decision2018-06-14
TypeNumberDevice NameCodeDateActions
510(k) K180401 TiWAVE-C™ Porous Titanium Cervical CageODP2018-06-14 View
510(k) K172808 CosmoLock Pedicle Screw SystemNKB2017-10-25 View
510(k) K172086 Matira™ Anterior Cervical SystemKWQ2017-09-22 View
510(k) K170342 Ocata Anterior Cervical SystemKWQ2017-05-09 View
510(k) K163471 Kalitec Direct InSePtion™ MIS Fixation SystemPEK2017-03-16 View