Medical Device Manufacturer · US , Little Silver , NJ

Additive Orthopaedics, LLC - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2016

Total

Cleared

Denied

Additive Orthopaedics, LLC has 6 FDA 510(k) cleared medical devices. Based in Little Silver, US.

Last cleared in 2022. Active since 2016. Primary specialty: Orthopedic.

Browse the FDA 510(k) cleared devices submitted by Additive Orthopaedics, LLC Filter by specialty or product code using the sidebar.

510(k) submissions have been managed by Paragon 28, Inc. as regulatory consultant.

FDA 510(k) Regulatory Record - Additive Orthopaedics, LLC

6 devices

1-6 of 6

Data Source

Sourced from the FDA 510(k) public files . 174,883 total devices indexed.

Last updated: May 19, 2026