FDA 510(k)

SpaceFix Shoulder Spacer

K-Number: K252443 · 2025-09-15

Decision Date2025-09-15

Product CodeMBB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SpaceFix Shoulder Spacer is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2025-09-15 under approval number K252443. 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 SpaceFix Shoulder Spacer?

SpaceFix Shoulder Spacer is a medical device that received FDA 510(k) clearance on 2025-09-15. It is manufactured by G21, S.R.L.. The 510(k) number is K252443.

When was SpaceFix Shoulder Spacer approved by the FDA?

SpaceFix Shoulder Spacer received FDA 510(k) clearance on 2025-09-15, under approval number K252443.

What company makes SpaceFix Shoulder Spacer?

SpaceFix Shoulder Spacer is manufactured by G21, S.R.L..

What is the FDA product code for SpaceFix Shoulder Spacer?

The FDA product code for SpaceFix Shoulder Spacer is MBB.

Other Devices by G21, S.R.L.

K152557Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters K173494OrthoSteady G Bone Cement K192041G21 SpaceFlex Hip K190216SpaceFlex Knee K181282G3A 40 Bone Cement K201960SpaceFlex Knee - 80mm Size

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Related Devices (Code: MBB)

K161166StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, Inc. K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder ProsthesisBiomet, Inc. K161273StageOne Disposable Cement Spacer Molds for Temporary Knee ProsthesisBiomet, Inc. K192041G21 SpaceFlex HipG21, S.R.L. K190216SpaceFlex KneeG21, S.R.L. K201960SpaceFlex Knee - 80mm SizeG21, S.R.L.

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.