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Kalitec Direct, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
9
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K180401TiWAVE-C™ Porous Titanium Cervical CageJune 14, 2018
K172808CosmoLock Pedicle Screw SystemOctober 25, 2017
K172086Matira™ Anterior Cervical SystemSeptember 22, 2017
K170342Ocata Anterior Cervical SystemMay 9, 2017
K163471Kalitec Direct InSePtion™ MIS Fixation SystemMarch 16, 2017
K140678COSMOLOCK PEDICLE SCREW SYSTEMJune 19, 2014
K133815INTESS CERVICAL CAGE SYSTEMApril 16, 2014
K123100INTESS LUMBAR CAGEMarch 28, 2013
K111370ODALYS PEDICLE SCREW SYSTEMSeptember 21, 2011