Trabis

FDA 510(k) K173893 · Coligne AG

Substantially Equivalent

510(k) numberK173893

Submission

Device name
Trabis
Applicant
Coligne AG
Zurich, CH
Received
December 21, 2017
Decision date
September 6, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
PLR – Spinal Vertebral Body Replacement Device - Cervical
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3060
Specialty
Orthopedic
Implant
Yes

Vertebral body replacement in the cervical spine.

Other 510(k)s with product code PLR

510(k)DeviceApplicantDecision
K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantPLR · Traditional Atlas Spine, Inc.07/15/2026SE
K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemPLR · Traditional Atlas Spine, Inc.11/10/2025SE
K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemPLR · Traditional MiRus, LLC10/13/2023SE
K221542Galileo Vertebral Body Replacement DevicePLR · Special Bright Spine01/13/2023SE
K212126MediExpand Cervical Expandable VBR SystemPLR · Traditional Cmf Medicon Surgical, Inc.04/04/2022SE
K211320CAPRI Corpectomy Cage SystemPLR · Traditional K2m, Inc.02/24/2022SE
K192145Galileo Vertebral Body Replacement DevicePLR · Traditional Bright Spine04/21/2020SE
K193412NEXXT MATRIXX SystemPLR · Traditional Nexxt Spine, LLC02/24/2020SE
K190284Bengal Stackable Cage SystemPLR · Traditional Medos International SARL12/20/2019SE
K190426ALTA Anterior Cervical Corpectomy SystemPLR · Traditional Astura Medical, LLC10/24/2019SE

More from Astura Medical, LLC

510(k)DeviceDecision
K210306GII Spinal Fixation SystemNKB · Special 05/19/2021SE
K181963ostaPek Interbody Fusion CagesMAX · Traditional 11/14/2018SE
K173148AcifODP · Traditional 12/01/2017SE

Questions and answers

When was Trabis cleared by the FDA?

Trabis (K173893) received a 510(k) decision of Substantially Equivalent on September 6, 2018, 259 days after the submission was received.

What is the product code of K173893?

The FDA product code is PLR – Spinal Vertebral Body Replacement Device - Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3060.