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FDA 510(k)

StageOne™ Shoulder Cement Spacer Molds

K-Number: K221968 · 2022-09-15

ApplicantBiomet, Inc.
Decision Date2022-09-15
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StageOne™ Shoulder Cement Spacer Molds is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2022-09-15 under approval number K221968. 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™ Shoulder Cement Spacer Molds?

StageOne™ Shoulder Cement Spacer Molds is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Biomet, Inc.. The 510(k) number is K221968.

When was StageOne™ Shoulder Cement Spacer Molds approved by the FDA?

StageOne™ Shoulder Cement Spacer Molds received FDA 510(k) clearance on 2022-09-15, under approval number K221968.

What company makes StageOne™ Shoulder Cement Spacer Molds?

StageOne™ Shoulder Cement Spacer Molds is manufactured by Biomet, Inc..

What is the FDA product code for StageOne™ Shoulder Cement Spacer Molds?

The FDA product code for StageOne™ Shoulder Cement Spacer Molds is MBB.

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. 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.

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