TrueLok Evo
K-Number: K212044 · 2021-11-05
ApplicantOrthofix Srl
Decision Date2021-11-05
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TrueLok Evo is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2021-11-05 under approval number K212044. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the TrueLok Evo?
TrueLok Evo is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Orthofix Srl. The 510(k) number is K212044.
When was TrueLok Evo approved by the FDA?
TrueLok Evo received FDA 510(k) clearance on 2021-11-05, under approval number K212044.
What company makes TrueLok Evo?
TrueLok Evo is manufactured by Orthofix Srl.
What is the FDA product code for TrueLok Evo?
The FDA product code for TrueLok Evo is KTT.
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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.