Medical Device Manufacturer · US , Cleveland , OH

Custom Orthopaedic Solutions, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2014

Recent clearances: Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis Preoperative Plan, SmartBase for Arthrex Glenoid IRIS, ArthrexVIP Web Portal, ArthrexVIP Web Portal, SmartBase for Arthrex Glenoid IRIS

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Custom Orthopaedic Solutions, Inc. Orthopedic ✕

3 devices

1-3 of 3

Cleared Feb 10, 2017

Arthrex Glenoid Intelligent Reusable Instrument System, Arthrex OrthoVis...

Orthopedic · 136d

Cleared Feb 19, 2016

SmartBase for Arthrex Glenoid IRIS

Orthopedic · 106d

Cleared Nov 24, 2014

GLENOID INTELLIGENT REUSABLE INSTRUMENT SYSTEM (GLENOID IRIS)

Orthopedic · 124d

Data Source

Sourced from the FDA 510(k) public files . 176,325 total devices indexed.

Last updated: Sep 21, 2026