Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Shoulder Innovations, Inc.. It received FDA 510(k) clearance on 2019-11-29 under 510(k) 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. The listed applicant is Shoulder Innovations, Inc.. The 510(k) number is K192365.

When did Shoulder Innovations Total Shoulder System receive FDA 510(k) clearance?

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

Who is the listed applicant for Shoulder Innovations Total Shoulder 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 Shoulder Innovations Total Shoulder System?

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

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

View all 8 devices →

Related Devices (Code: KWT)

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.

K250713Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsExactech, Inc.K251686Tornier Humeral Reconstruction System Max (Tornier HRS Max)Tornier, Inc.K241944AGILON® XO Shoulder Replacement SystemImplantcast GmbHK241817InSet Total Shoulder SystemShoulder Innovations, Inc.K231657AGILON® XO Shoulder Replacement SystemImplantcast GmbHK223631Comprehensive Segmental Revision System(SRS)Biomet Orthopedics

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.

↑