TrueLok Elevate
K-Number: K242861 · 2024-12-03
ApplicantOrthofix Srl
Decision Date2024-12-03
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
TrueLok Elevate is a medical device manufactured by Orthofix Srl. It received FDA 510(k) clearance on 2024-12-03 under approval number K242861. 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 Elevate?
TrueLok Elevate is a medical device that received FDA 510(k) clearance on 2024-12-03. It is manufactured by Orthofix Srl. The 510(k) number is K242861.
When was TrueLok Elevate approved by the FDA?
TrueLok Elevate received FDA 510(k) clearance on 2024-12-03, under approval number K242861.
What company makes TrueLok Elevate?
TrueLok Elevate is manufactured by Orthofix Srl.
What is the FDA product code for TrueLok Elevate?
The FDA product code for TrueLok Elevate 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.