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FDA 510(k)

SpaceFlex Shoulder

K-Number: K202338 · 2021-02-17

ApplicantG21, S.R.L.
Decision Date2021-02-17
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SpaceFlex Shoulder 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 2021-02-17 under 510(k) number K202338. 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 SpaceFlex Shoulder?

SpaceFlex Shoulder is a medical device that received FDA 510(k) clearance on 2021-02-17. The listed applicant is G21, S.R.L.. The 510(k) number is K202338.

When did SpaceFlex Shoulder receive FDA 510(k) clearance?

SpaceFlex Shoulder received FDA 510(k) clearance on 2021-02-17, under 510(k) number K202338.

Who is the listed applicant for SpaceFlex Shoulder?

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 Shoulder?

The FDA product code for SpaceFlex Shoulder 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 CupK201960SpaceFlex Knee - 80mm SizeK193061G3 40 Radiopaque Bone CementK193059G1 40 Radiopaque Bone CementK192041G21 SpaceFlex Hip

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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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