Kalitec Direct L L C

FDA Filings

This page includes the latest FDA filings for Kalitec Direct L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3009165919
FEI Number3009165919
NameKalitec Direct LLC DBA Kalitec Medical
Owner & OperatorKalitec Medical
Contact Address865 Oviedo Blvd Suite 1017
Oviedo FL 32765 US
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address865 Oviedo Blvd Suite 1017
Oviedo, FL 32765 US
Establishment Type
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device

FDA Filings

Device
Company
DeviceDate
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-K01-70002024-03-11
Kalitec Direct LLC
 Cosmolock 10-BRS-02302024-01-24
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-95252023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-95152023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-95102023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-95052023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-95002023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85952023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85902023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85852023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85802023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85752023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85702023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85652023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85602023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85552023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85502023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85452023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85402023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85352023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85302023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85252023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85152023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85102023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85052023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-85002023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75952023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75902023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75852023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75802023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75752023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75702023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75652023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75602023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75552023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75502023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75452023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75402023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75352023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75302023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75252023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75152023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75102023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75052023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-75002023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65952023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65902023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65852023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65802023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65752023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65702023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65652023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65602023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65552023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65502023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65452023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65402023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65352023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65302023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65252023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65152023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65102023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65052023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-65002023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55652023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55602023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55552023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55502023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55452023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55402023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55352023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55302023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-55252023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47652023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47602023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47552023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47502023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47452023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47402023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47352023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC47302023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-47252023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 05-BCC-05952023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05902023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05852023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05802023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05752023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 05-BCC-05652023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05602023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05552023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05502023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05452023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05402023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05352023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05302023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05252023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05152023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05102023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05052023-10-16
Kalitec Direct LLC
 NIDO Pedicle Screw System 15-BCC-05002023-10-16
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
Kalitec Disc Prep 3 mm Up Biting Pituitary2019-12-27
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
Kalitec Disc Prep 3 mm Straight Pituitary2019-12-27
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
CosmoLock Pedicle Screw System2018-06-20
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
Matira Anterior Cervical System2018-06-20
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
TiWAVE L Lumber Trial, 25 x 14mm, 0 Deg, NT STR2018-06-20
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
TiWAVE L Lumber Trial, 22 x 16mm, 0 Deg, NT STR2018-06-20
Kalitec Direct, LLC
CosmoLock Pedicle Screw System2017-10-25
Kalitec Direct, LLC
Matira™ Anterior Cervical System2017-09-22
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
Ocata Anterior Cervical System2017-07-18
Kalitec Direct, LLC
Ocata Anterior Cervical System2017-05-09
Kalitec Direct LLC DBA Kalitec Medical [Kalitec Medical]
InSePtion MIS Fixation System2017-03-21
KALITEC DIRECT, LLC
Kalitec Direct InSePtion™ MIS Fixation System2017-03-16
KALITEC DIRECT, LLC
COSMOLOCK PEDICLE SCREW SYSTEM2014-06-19
KALITEC DIRECT, LLC
INTESS CERVICAL CAGE SYSTEM2014-04-16
KALITEC DIRECT, LLC
INTESS LUMBAR CAGE2013-03-28
KALITEC DIRECT, LLC
ODALYS PEDICLE SCREW SYSTEM2011-09-21

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