Shoulder Innovations, Inc. - FDA 510(k) Cleared Devices
Recent clearances: N22 Offset Humeral Head, InSet Reverse Total Shoulder System, N22 EZ Glenosphere
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shoulder Innovations, Inc. Orthopedic ✕
9 devices
Cleared
Sep 08, 2026
N22 Offset Humeral Head
Orthopedic
74d
Cleared
Apr 13, 2026
InSet Reverse Total Shoulder System
Orthopedic
112d
Cleared
Jan 15, 2026
N22 EZ Glenosphere
Orthopedic
157d
Cleared
Sep 26, 2025
Inset Reverse Total Shoulder System
Orthopedic
72d
Cleared
Feb 11, 2025
InSet Total Shoulder System
Orthopedic
232d
Cleared
Mar 11, 2022
Shoulder Innovations Total Shoulder System
Orthopedic
116d
Cleared
Aug 20, 2021
Inset Reverse Total Shoulder System
Orthopedic
177d
Cleared
Nov 29, 2019
Shoulder Innovations Total Shoulder System
Orthopedic
91d
Cleared
Oct 23, 2018
Humeral Short Stem System
Orthopedic
309d