TiWAVE-C Porous Titanium Cervical Cage
K-Number: K180401 · 2018-06-14
ApplicantKalitec Direct, LLC
Decision Date2018-06-14
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TiWAVE-C Porous Titanium Cervical Cage is a medical device manufactured by Kalitec Direct, LLC. It received FDA 510(k) clearance on 2018-06-14 under approval number K180401. The device is classified under product code ODP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TiWAVE-C Porous Titanium Cervical Cage?
TiWAVE-C Porous Titanium Cervical Cage is a medical device that received FDA 510(k) clearance on 2018-06-14. It is manufactured by Kalitec Direct, LLC. The 510(k) number is K180401.
When was TiWAVE-C Porous Titanium Cervical Cage approved by the FDA?
TiWAVE-C Porous Titanium Cervical Cage received FDA 510(k) clearance on 2018-06-14, under approval number K180401.
What company makes TiWAVE-C Porous Titanium Cervical Cage?
TiWAVE-C Porous Titanium Cervical Cage is manufactured by Kalitec Direct, LLC.
What is the FDA product code for TiWAVE-C Porous Titanium Cervical Cage?
The FDA product code for TiWAVE-C Porous Titanium Cervical Cage is ODP.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.