Medical Device Manufacturer · CH , Zurich

Coligne AG - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2017

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Coligne AG Orthopedic ✕

4 devices

1-4 of 4

Cleared May 19, 2021

GII Spinal Fixation System

Orthopedic · 105d

Cleared Nov 14, 2018

ostaPek Interbody Fusion Cages

Orthopedic · 114d

Cleared Sep 06, 2018

Orthopedic · 259d

Cleared Dec 01, 2017

Orthopedic · 63d

Data Source

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

Last updated: May 23, 2026