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FDA 510(k)

Shoulder Innovations Total Shoulder System

K-Number: K192365 · 2019-11-29

ApplicantShoulder Innovations, Inc.
Decision Date2019-11-29
Product CodeKWT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Shoulder Innovations Total Shoulder System is a medical device manufactured by Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2019-11-29 under approval number K192365. The device is classified under product code KWT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Shoulder Innovations Total Shoulder System?

Shoulder Innovations Total Shoulder System is a medical device that received FDA 510(k) clearance on 2019-11-29. It is manufactured by Shoulder Innovations, Inc.. The 510(k) number is K192365.

When was Shoulder Innovations Total Shoulder System approved by the FDA?

Shoulder Innovations Total Shoulder System received FDA 510(k) clearance on 2019-11-29, under approval number K192365.

What company makes Shoulder Innovations Total Shoulder System?

Shoulder Innovations Total Shoulder System is manufactured by Shoulder Innovations, Inc..

What is the FDA product code for Shoulder Innovations Total Shoulder System?

The FDA product code for Shoulder Innovations Total Shoulder System is KWT.

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

Other Devices by Shoulder Innovations, Inc.

K173824Humeral Short Stem System K210533Inset Reverse Total Shoulder System K213615Shoulder Innovations Total Shoulder System K252221Inset Reverse Total Shoulder System K241817InSet Total Shoulder System K254128InSet Reverse Total Shoulder System

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Related Devices (Code: KWT)

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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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