Medical Device Manufacturer · US , Cleveland , OH

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

6 submissions · 6 cleared · Since 2014

Total

Cleared

Denied

Custom Orthopaedic Solutions, Inc. has 6 FDA 510(k) cleared medical devices. Based in Cleveland, US.

Historical record: 6 cleared submissions from 2014 to 2017. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Custom Orthopaedic Solutions, Inc. Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Custom Orthopaedic Solutions as regulatory consultant.

Custom Orthopaedic Solutions, Inc. is one of 19020 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

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

6 devices

1-6 of 6

Data Source

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

Last updated: Sep 21, 2026