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FDA 510(k)

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis

K-Number: K160071 · 2016-06-16

ApplicantBiomet, Inc.
Decision Date2016-06-16
Product CodeMBB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is a medical device manufactured by Biomet, Inc.. It received FDA 510(k) clearance on 2016-06-16 under approval number K160071. 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 Hemi-Shoulder Prosthesis?

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is a medical device that received FDA 510(k) clearance on 2016-06-16. It is manufactured by Biomet, Inc.. The 510(k) number is K160071.

When was StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis approved by the FDA?

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis received FDA 510(k) clearance on 2016-06-16, under approval number K160071.

What company makes StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis?

StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is manufactured by Biomet, Inc..

What is the FDA product code for StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis?

The FDA product code for StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis is MBB.

Related Clinical Trials

NCT05615844 Antibiotic Cement Bead Pouch Versus Negative Pressure Wound Therapy RECRUITING NCT07559058 Perineural Injection Treatment for Shoulder Pain COMPLETED NCT07495254 Effectiveness of Combined Super Inductive System (SIS) Therapy With Therapeutic Exercise and Health Education in Lateral Elbow Tendinopathy NOT_YET_RECRUITING

Other Devices by Biomet, Inc.

K161592Persona Partial Knee System K162424Ulna Plating System K161166StageOne Select Cement Spacer Molds for Temporary Hip Replacement K161190G7 Dual Mobility System, Active Articulation System K153657Vanguard XP Knee System K160058Biomet Variable Pitch Compression Screw System

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Related Devices (Code: MBB)

K161166StageOne Select Cement Spacer Molds for Temporary Hip ReplacementBiomet, 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. 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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