Trabis— 510(k) K173893

Substantially Equivalent

Coligne AG

FDA 510(k) clearance K173893 for Trabis, Substantially Equivalent on 2018-09-06. Applicant: Coligne AG. Device class: 2.

Clearance details

Applicant: Coligne AG
Product code: Code PLR
Device class: Class 2
Regulation: 21 CFR 888.3060
Advisory panel: Orthopedic
Date received: 2017-12-21
Decision date: 2018-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Zurich, CH

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLR

K252822 — Atlas Spine HiRISE Expandable Cervical-p Corpectomy Implant2026-07-15
K252560 — Atlas Spine HiRISE Expandable Cervical Corpectomy System2025-11-10
K232481 — RIGEL 3DR Anterior Cervical Corpectomy System2023-10-13
K221542 — Galileo Vertebral Body Replacement Device2023-01-13
K212126 — MediExpand Cervical Expandable VBR System2022-04-04

More clearances from Coligne AG

K210306 — GII Spinal Fixation System2021-05-19
K181963 — ostaPek Interbody Fusion Cages2018-11-14
K173148 — ACIF2017-12-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.