K-number	K240889
Device name	ARTFX Lumbar PEEK Cages
Applicant	Artfx Medical
Product code	MAX
Device class	Class II
Decision date	Oct 2, 2024
Decision	Substantially Equivalent
Regulation	888.3080

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Source

View the full FDA submission: accessdata.fda.gov

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ARTFX Lumbar PEEK Cages

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