Medical Device Manufacturer · US , Round Rock , TX

Kalitec Direct, LLC - FDA 510(k) Cleared Devices

9 submissions · 9 cleared · Since 2011

Recent clearances: TiWAVE-C™ Porous Titanium Cervical Cage, CosmoLock Pedicle Screw System, Matira™ Anterior Cervical System

9
Total
9
Cleared
0
Denied

FDA 510(k) Regulatory Record - Kalitec Direct, LLC Orthopedic ✕

9 devices
1-9 of 9
Cleared Jun 14, 2018
TiWAVE-C™ Porous Titanium Cervical Cage
K180401 · ODP
Orthopedic · 120d
Cleared Oct 25, 2017
CosmoLock Pedicle Screw System
K172808 · NKB
Orthopedic · 37d
Cleared Sep 22, 2017
Matira™ Anterior Cervical System
K172086 · KWQ
Orthopedic · 73d
Cleared May 09, 2017
Ocata Anterior Cervical System
K170342 · KWQ
Orthopedic · 95d
Cleared Mar 16, 2017
Kalitec Direct InSePtion™ MIS Fixation System
K163471 · PEK
Orthopedic · 94d
Cleared Jun 19, 2014
COSMOLOCK PEDICLE SCREW SYSTEM
K140678 · MNH
Orthopedic · 93d
Cleared Apr 16, 2014
INTESS CERVICAL CAGE SYSTEM
K133815 · ODP
Orthopedic · 121d
Cleared Mar 28, 2013
INTESS LUMBAR CAGE
K123100 · MAX
Orthopedic · 177d
Cleared Sep 21, 2011
ODALYS PEDICLE SCREW SYSTEM
K111370 · MNH
Orthopedic · 128d
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