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FDA 510(k)

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis

K-Number: K161273 · 2017-01-25

ApplicantBiomet, Inc.
Decision Date2017-01-25
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2017-01-25 under approval number K161273. 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 StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis?

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis is a medical device that received FDA 510(k) clearance on 2017-01-25. It is manufactured by Biomet, Inc.. The 510(k) number is K161273.

When was StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis approved by the FDA?

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis received FDA 510(k) clearance on 2017-01-25, under approval number K161273.

What company makes StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis?

StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis is manufactured by Biomet, Inc..

What is the FDA product code for StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis?

The FDA product code for StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis is MBB.

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Other Devices by Biomet, Inc.

K161592Persona Partial Knee System K162424Ulna Plating System K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement K160071StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System

View all 34 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. K192041G21 SpaceFlex HipG21, S.R.L. K190216SpaceFlex KneeG21, 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.

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