TiWAVE-L Porous Titanium Lumbar Cage
K-Number: K182210 · 2019-01-07
ApplicantKalitec Medical, LLC
Decision Date2019-01-07
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TiWAVE-L Porous Titanium Lumbar Cage is a medical device manufactured by Kalitec Medical, LLC. It received FDA 510(k) clearance on 2019-01-07 under approval number K182210. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TiWAVE-L Porous Titanium Lumbar Cage?
TiWAVE-L Porous Titanium Lumbar Cage is a medical device that received FDA 510(k) clearance on 2019-01-07. It is manufactured by Kalitec Medical, LLC. The 510(k) number is K182210.
When was TiWAVE-L Porous Titanium Lumbar Cage approved by the FDA?
TiWAVE-L Porous Titanium Lumbar Cage received FDA 510(k) clearance on 2019-01-07, under approval number K182210.
What company makes TiWAVE-L Porous Titanium Lumbar Cage?
TiWAVE-L Porous Titanium Lumbar Cage is manufactured by Kalitec Medical, LLC.
What is the FDA product code for TiWAVE-L Porous Titanium Lumbar Cage?
The FDA product code for TiWAVE-L Porous Titanium Lumbar Cage is MAX.
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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.