K-number	K242861
Device name	TrueLok Elevate
Applicant	Orthofix Srl
Product code	KTT
Device class	Class II
Decision date	Dec 3, 2024
Decision	Substantially Equivalent
Regulation	888.3030

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Source

View the full FDA submission: accessdata.fda.gov

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TrueLok Elevate

Everything you need for a 510(k) submission. Nothing you don't.