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FDA 510(k)

G21 SpaceFlex Hip

K-Number: K192041 · 2019-10-29

ApplicantG21, S.R.L.
Decision Date2019-10-29
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G21 SpaceFlex Hip 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 2019-10-29 under 510(k) number K192041. The device is classified under product code MBB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the G21 SpaceFlex Hip?

G21 SpaceFlex Hip is a medical device that received FDA 510(k) clearance on 2019-10-29. The listed applicant is G21, S.R.L.. The 510(k) number is K192041.

When did G21 SpaceFlex Hip receive FDA 510(k) clearance?

G21 SpaceFlex Hip received FDA 510(k) clearance on 2019-10-29, under 510(k) number K192041.

Who is the listed applicant for G21 SpaceFlex Hip?

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 G21 SpaceFlex Hip?

The FDA product code for G21 SpaceFlex Hip is MBB.

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.

K252443SpaceFix Shoulder SpacerK223441SpaceFlex Acetabular CupK202338SpaceFlex ShoulderK201960SpaceFlex Knee - 80mm SizeK193061G3 40 Radiopaque Bone CementK193059G1 40 Radiopaque Bone Cement

View all 11 devices →

Related Devices (Code: MBB)

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.

K252443SpaceFix Shoulder SpacerG21, S.R.L.K242216GENTAFIX® (1, 3, 3MV)Teknimed SasK240856Hip Spacer Molds; Knee Spacer Molds; Shoulder Spacer MoldsOsartis GmbHK222760StageOne™ Select Hip Cement Spacer MoldsBiomet, Inc.K221968StageOne™ Shoulder Cement Spacer MoldsBiomet, Inc.K213287StageOne Knee Cement Spacer MoldsBiomet, 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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