FDA 510(k) Applications Submitted by Kalitec Direct, LLC

FDA 510(k) Number Submission Date Device Name Applicant
K123100 10/02/2012 INTESS LUMBAR CAGE KALITEC DIRECT, LLC
K140678 03/18/2014 COSMOLOCK PEDICLE SCREW SYSTEM KALITEC DIRECT, LLC
K111370 05/16/2011 ODALYS PEDICLE SCREW SYSTEM KALITEC DIRECT, LLC
K133815 12/16/2013 INTESS CERVICAL CAGE SYSTEM KALITEC DIRECT, LLC
K172086 07/11/2017 MatiraÖ Anterior Cervical System Kalitec Direct, LLC
K163471 12/12/2016 Kalitec Direct InSePtionÖ MIS Fixation System KALITEC DIRECT, LLC
K170342 02/03/2017 Ocata Anterior Cervical System Kalitec Direct, LLC
K180401 02/14/2018 TiWAVE-CÖ Porous Titanium Cervical Cage Kalitec Direct, LLC
K172808 09/18/2017 CosmoLock Pedicle Screw System Kalitec Direct, LLC


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