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Shoulder Innovations, Inc.

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories4
Latest FDA decision2026-04-13

SEC Filings: 1 filings on record. Latest: 10-Q (2026-08-06). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
510(k) K254128 InSet Reverse Total Shoulder SystemPHX2026-04-13 View
510(k) K252516 N22 EZ GlenospherePHX2026-01-15 View
510(k) K252221 Inset Reverse Total Shoulder SystemPHX2025-09-26 View
510(k) K241817 InSet Total Shoulder SystemKWT2025-02-11 View
510(k) K213615 Shoulder Innovations Total Shoulder SystemPKC2022-03-11 View
510(k) K210533 Inset Reverse Total Shoulder SystemPHX2021-08-20 View
510(k) K192365 Shoulder Innovations Total Shoulder SystemKWT2019-11-29 View
510(k) K173824 Humeral Short Stem SystemMBF2018-10-23 View
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