FDA 510(k)

SpaceFlex Knee - 80mm Size

K-Number: K201960 · 2020-08-13

Decision Date2020-08-13

Product CodeMBB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SpaceFlex Knee - 80mm Size is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2020-08-13 under approval number K201960. 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 Knee - 80mm Size?

SpaceFlex Knee - 80mm Size is a medical device that received FDA 510(k) clearance on 2020-08-13. It is manufactured by G21, S.R.L.. The 510(k) number is K201960.

When was SpaceFlex Knee - 80mm Size approved by the FDA?

SpaceFlex Knee - 80mm Size received FDA 510(k) clearance on 2020-08-13, under approval number K201960.

What company makes SpaceFlex Knee - 80mm Size?

SpaceFlex Knee - 80mm Size is manufactured by G21, S.R.L..

What is the FDA product code for SpaceFlex Knee - 80mm Size?

The FDA product code for SpaceFlex Knee - 80mm Size 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 K193059G1 40 Radiopaque Bone Cement

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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. K202338SpaceFlex ShoulderG21, 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.