K-number	K240085
Device name	zLOCK Lumbar Facet Fixation System
Applicant	Zygofix , Ltd.
Product code	MRW
Device class	Class U
Decision date	Apr 18, 2024
Decision	Substantially Equivalent
Regulation	—

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Source

View the full FDA submission: accessdata.fda.gov

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zLOCK Lumbar Facet Fixation System

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