Data / Medical devices / Switzerland / Coligne AG

Coligne AG: FDA-registered device maker in Zurich, Switzerland, 9 510(k) clearances

Name: Coligne AG FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Coligne AG is registered with the FDA (registration 1000493591) in Zurich, Switzerland. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 19, 2021. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1000493591
Address: Utoquai 43, Zurich, Switzerland, 8008
Owner or operator: COLIGNE AG (9033198)
Roles: Manufacturer
First device listed: January 17, 2008
Registered through: 2026
Brand names listed: ACIF, GII, GII Spinal Fixation System, OstaPek VBR System, Trabis, ostaPek, ostaPek Interbody Fusion Cages

Devices it lists

Device	Product code	Class	Role	Source
Appliance, Fixation, Spinal Interlaminal	KWP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2	Manufacturer	accessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, Lumbar	MAX	2	Manufacturer	accessdata.fda.gov
Orthosis, Spinal Pedicle Fixation	MNI	2	Manufacturer	accessdata.fda.gov
Orthosis, Spondylolisthesis Spinal Fixation	MNH	2	Manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device	MQP	2	Manufacturer	accessdata.fda.gov
Spinal Vertebral Body Replacement Device - Cervical	PLR	2	Manufacturer	accessdata.fda.gov
Thoracolumbosacral Pedicle Screw System	NKB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 19, 2021	K210306	GII Spinal Fixation System	NKB	Substantially Equivalent	Coligne AG	accessdata.fda.gov
November 14, 2018	K181963	ostaPek Interbody Fusion Cages	MAX	Substantially Equivalent	Coligne AG	accessdata.fda.gov
September 6, 2018	K173893	Trabis	PLR	Substantially Equivalent	Coligne AG	accessdata.fda.gov
December 1, 2017	K173148	ACIF	ODP	Substantially Equivalent	Coligne AG	accessdata.fda.gov
September 14, 2009	K083567	GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW	MNH	Substantially Equivalent	Co-Ligne AG	accessdata.fda.gov
June 24, 2008	K072326	OSTAPEK VBR SYSTEM	MQP	Substantially Equivalent	Co-Ligne AG	accessdata.fda.gov
October 26, 2005	K051089	GII SPINAL FIXATION SYSTEM	MNH	Substantially Equivalent	Co-Ligne AG	accessdata.fda.gov
January 20, 2004	K032604	GII SPINAL FIXATION SYSTEM	MNH	Substantially Equivalent	Co-Ligne AG	accessdata.fda.gov
May 1, 1998	K980852	GII SPINAL FIXATION SYSTEM	MNH	Substantially Equivalent	Karen E. Warden, M.E.B.E.	accessdata.fda.gov

Compare with other makers

Updated May 19, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.