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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 the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2018-10-23 under 510(k) 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. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K173824.

When did Humeral Short Stem System receive FDA 510(k) clearance?

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

Who is the listed applicant for Humeral Short Stem System?

The FDA 510(k) record lists Shoulder Innovations, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06371833PRIMA EU Retrospective & ProspectiveRECRUITING

Other records listing Shoulder Innovations, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254128InSet Reverse Total Shoulder SystemK252516N22 EZ GlenosphereK252221Inset Reverse Total Shoulder SystemK241817InSet Total Shoulder SystemK213615Shoulder Innovations Total Shoulder SystemK210533Inset Reverse Total Shoulder System

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Related Devices (Code: MBF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)Zimmer, Inc.K251098Identity Revision Humeral StemsZimmer, Inc.K250848Identity Shoulder SystemZimmer, Inc.K240876Identity Shoulder SystemZimmer, Inc.K233712PRIMA Humeral System; PRIMA TT GlenoidLima Corporate S.P.A.K231099SMR Hybrid Glenoid SystemLima Corporate S.P.A.

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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