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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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