FDA.reportPublic FDA data

Kalitec Direct LLC DBA Kalitec Medical

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30091659193009165919Kalitec Direct LLC DBA Kalitec Medical1N2026-01-011819 Main St Ste 303 Sarasota FL US 34236

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1315081968472600K232572Kalitec Navigated Instrument SystemOLO2023-12-13
1315081665545154K230974NIDO™ Pedicle Screw SystemNKB2023-09-15
1315081785536330K220902Navagio Lumbar CageMAX2022-05-27
1315081639632920K172808CosmoLock Pedicle Screw SystemNKB2017-10-25
1315082041111679K172086Matira™ Anterior Cervical SystemKWQ2017-09-22
1315081731301773K170342Ocata Anterior Cervical SystemKWQ2017-05-09
1315081291982536K163471Kalitec Direct InSePtion™ MIS Fixation SystemPEK2017-03-16
1315081879489042K140678COSMOLOCK PEDICLE SCREW SYSTEMMNH2014-06-19
1315081254310563K133815INTESS CERVICAL CAGE SYSTEMODP2014-04-16
1315081042004101K123100INTESS LUMBAR CAGEMAX2013-03-28
1315081004191476
1315081087640483
1315081134248752
1315081211318917
1315081222454823
1315081229111634
1315081233628198
1315081290033051
1315081330327261
1315081351053142
1315081356515250
1315081358644838
1315081362670278
1315081368884351
1315081440441889
1315081514952064
1315081566362025
1315081581522853
1315081609824511
1315081690364275
1315081721310020
1315081765296460
1315081768628486
1315081772532927
1315081775527778
1315081777956640
1315081808705908
1315081838816886
1315081844491538
1315081865475706
1315081872374110
1315081901283431
1315081912919553

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NKB22023-09-15
MAX22022-05-27
KWQ22017-09-22
OLO12023-12-13
PEK12017-03-16
MNH12014-06-19
ODP12014-04-16