Kalitec Direct, LLC - FDA 510(k) Cleared Devices
9
Total
9
Cleared
0
Denied
9 devices
Cleared
Jun 14, 2018
TiWAVE-C™ Porous Titanium Cervical Cage
Orthopedic
120d
Cleared
Oct 25, 2017
CosmoLock Pedicle Screw System
Orthopedic
37d
Cleared
Sep 22, 2017
Matira™ Anterior Cervical System
Orthopedic
73d
Cleared
May 09, 2017
Ocata Anterior Cervical System
Orthopedic
95d
Cleared
Mar 16, 2017
Kalitec Direct InSePtion™ MIS Fixation System
Orthopedic
94d
Cleared
Jun 19, 2014
COSMOLOCK PEDICLE SCREW SYSTEM
Orthopedic
93d
Cleared
Apr 16, 2014
INTESS CERVICAL CAGE SYSTEM
Orthopedic
121d
Cleared
Mar 28, 2013
INTESS LUMBAR CAGE
Orthopedic
177d
Cleared
Sep 21, 2011
ODALYS PEDICLE SCREW SYSTEM
Orthopedic
128d