SpaceFlex Acetabular Cup
K-Number: K223441 · 2023-03-23
ApplicantG21, S.R.L.
Decision Date2023-03-23
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SpaceFlex Acetabular Cup is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2023-03-23 under approval number K223441. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SpaceFlex Acetabular Cup?
SpaceFlex Acetabular Cup is a medical device that received FDA 510(k) clearance on 2023-03-23. It is manufactured by G21, S.R.L.. The 510(k) number is K223441.
When was SpaceFlex Acetabular Cup approved by the FDA?
SpaceFlex Acetabular Cup received FDA 510(k) clearance on 2023-03-23, under approval number K223441.
What company makes SpaceFlex Acetabular Cup?
SpaceFlex Acetabular Cup is manufactured by G21, S.R.L..
What is the FDA product code for SpaceFlex Acetabular Cup?
The FDA product code for SpaceFlex Acetabular Cup is KWY.
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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.