FDA 510(k)

SpaceFlex Knee

K-Number: K190216 · 2019-06-09

Decision Date2019-06-09

Product CodeMBB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SpaceFlex Knee is a medical device manufactured by G21, S.R.L.. It received FDA 510(k) clearance on 2019-06-09 under approval number K190216. 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?

SpaceFlex Knee is a medical device that received FDA 510(k) clearance on 2019-06-09. It is manufactured by G21, S.R.L.. The 510(k) number is K190216.

When was SpaceFlex Knee approved by the FDA?

SpaceFlex Knee received FDA 510(k) clearance on 2019-06-09, under approval number K190216.

What company makes SpaceFlex Knee?

SpaceFlex Knee is manufactured by G21, S.R.L..

What is the FDA product code for SpaceFlex Knee?

The FDA product code for SpaceFlex Knee 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 K181282G3A 40 Bone Cement K201960SpaceFlex Knee - 80mm Size K193059G1 40 Radiopaque Bone Cement

View all 11 devices →

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. K201960SpaceFlex Knee - 80mm SizeG21, 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.