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Kalitec Direct, LLC

USA · Round Rock

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

41listed device types

Class I 33Class II 8Class III 0

plus 43 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States43 registration records, 10 510(k), 0 PMA, 2 excluded

Manufacturer names merged into this page: Kalitec Direct LLC DBA Kalitec Medical

Same-named companies — This database also contains companies with near-identical names: Kalitec Direct LLC DBA Kalitec Medical, Kalitec Direct, LLC Doing Business AS Kalitec Medical, Kalitec Medical, LLC. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

12011

12013

22014 · K140678

42017 · K172808

12018 · K180401

12023 · K232572

FDA listed device types

showing 8 of 41

Template 1Rasp 1Probe 1Impactor 1Punch, Surgical 1Guide, Surgical, Instrument 1Instrument, Cutting, Orthopedic 1Screwdriver 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K232572	Kalitec Navigated Instrument System	2023-12-13
US	K180401	TiWAVE-C Porous Titanium Cervical Cage	2018-06-14
US	K172808	CosmoLock Pedicle Screw System	2017-10-25

Kalitec Direct, LLC

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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