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

9
Total
9
Cleared
0
Denied

Kalitec Direct, LLC has 9 FDA 510(k) cleared medical devices. Based in Round Rock, US.

Historical record: 9 cleared submissions from 2011 to 2018. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Kalitec Direct, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Cherry Tree Consulting as regulatory consultant.

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

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