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Shoulder Innovations, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252516N22 EZ GlenosphereJanuary 15, 2026
K252221Inset Reverse Total Shoulder SystemSeptember 26, 2025
K241817InSet Total Shoulder SystemFebruary 11, 2025
K213615Shoulder Innovations Total Shoulder SystemMarch 11, 2022
K210533Inset Reverse Total Shoulder SystemAugust 20, 2021
K192365Shoulder Innovations Total Shoulder SystemNovember 29, 2019
K173824Humeral Short Stem SystemOctober 23, 2018
K111596TOTAL SHOULDER SYSTEMJuly 5, 2011
K110905TOTAL SHOULDER SYSTEMMay 24, 2011
K102670TOTAL SHOULDER SYSTEMJanuary 24, 2011