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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is G21, S.R.L.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) 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. The listed applicant is G21, S.R.L.. The 510(k) number is K223441.

When did SpaceFlex Acetabular Cup receive FDA 510(k) clearance?

SpaceFlex Acetabular Cup received FDA 510(k) clearance on 2023-03-23, under 510(k) number K223441.

Who is the listed applicant for SpaceFlex Acetabular Cup?

The FDA 510(k) record lists G21, S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SpaceFlex Acetabular Cup?

The FDA product code for SpaceFlex Acetabular Cup is KWY.

Other records listing G21, S.R.L. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: KWY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical GmbHK200709Kyocera Bipolar Hip SystemKyocera Medical Technologies, Inc.

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.

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