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FDA 510(k)

Humeral Short Stem System

K-Number: K173824 · 2018-10-23

ApplicantShoulder Innovations, Inc.
Decision Date2018-10-23
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Humeral Short Stem System is a medical device manufactured by Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2018-10-23 under approval number K173824. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Humeral Short Stem System?

Humeral Short Stem System is a medical device that received FDA 510(k) clearance on 2018-10-23. It is manufactured by Shoulder Innovations, Inc.. The 510(k) number is K173824.

When was Humeral Short Stem System approved by the FDA?

Humeral Short Stem System received FDA 510(k) clearance on 2018-10-23, under approval number K173824.

What company makes Humeral Short Stem System?

Humeral Short Stem System is manufactured by Shoulder Innovations, Inc..

What is the FDA product code for Humeral Short Stem System?

The FDA product code for Humeral Short Stem System is MBF.

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Other Devices by Shoulder Innovations, Inc.

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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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