K-number	K223441
Device name	SpaceFlex Acetabular Cup
Applicant	G21, S.R.L.
Product code	KWY
Device class	Class II
Decision date	Mar 23, 2023
Decision	Substantially Equivalent
Regulation	888.3390

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Source

View the full FDA submission: accessdata.fda.gov

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SpaceFlex Acetabular Cup

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