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Data / Medical devices / Germany / Ulrich GMBH & Co. KG

Ulrich GMBH & Co. KG: FDA-registered device maker in ULM Baden-Wurttemberg, Germany, 18 510(k) clearances

Ulrich GMBH & Co. KG is registered with the FDA (registration 9612420) in ULM Baden-Wurttemberg, Germany. It lists 36 device types. The FDA files 18 510(k) clearances under its listings, the newest dated November 18, 2025. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Ulrich GMBH & Co. KG
FDA registration number
9612420
FEI number
3002807156
Address
Buchbrunnenweg 12, ULM Baden-Wurttemberg, Germany, D-89081
Owner or operator
ULRICH GMBH & CO. KG (8010776)
Roles
Contract manufacturer, Exporter to the US, Manufacturer
First device listed
April 1, 1994
Registered through
2026
Brand names listed
AddPlus, Anterior Distraction Dev., Cortium, Gouge, HARMS IMPACTOR, IMPLANT TRAY, Momentum™ Posterior Spinal Fixation System, Momentum® MIS Posterior Spinal Fixation System, Navigation Module of the Momentum System and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufacturer, Manufactureraccessdata.fda.gov
AwlHWJ1Manufactureraccessdata.fda.gov
Bit, DrillHTW1Manufactureraccessdata.fda.gov
Bone CementLOD2Exporter to the USaccessdata.fda.gov
Cement, Bone, VertebroplastyNDN2Exporter to the USaccessdata.fda.gov
Chisel, Surgical, ManualFZO1Manufactureraccessdata.fda.gov
Clamp, Surgical, General & Plastic SurgeryGDJ1Manufactureraccessdata.fda.gov
Curette, Surgical, General UseFZS1Manufactureraccessdata.fda.gov
ForcepsHTD1Manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Manufactureraccessdata.fda.gov
Gouge, Surgical, General & Plastic SurgeryGDH1Manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Manufactureraccessdata.fda.gov
Holder, Needle; OrthopedicHXK1Manufactureraccessdata.fda.gov
Hook, Surgical, General & Plastic SurgeryGDG1Manufactureraccessdata.fda.gov
ImpactorHWA1Manufactureraccessdata.fda.gov
Injector, Contrast Medium, AutomaticIZQ2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufactureraccessdata.fda.gov
Orthosis, Spinal Pedicle FixationMNI2Manufactureraccessdata.fda.gov
Orthosis, Spondylolisthesis Spinal FixationMNH2Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Contract manufacturer, Manufactureraccessdata.fda.gov
ProbeHXB1Manufactureraccessdata.fda.gov
Pusher, SocketHXO1Manufactureraccessdata.fda.gov
ReamerHTO1Manufactureraccessdata.fda.gov
RetractorGAD1Manufactureraccessdata.fda.gov
RongeurHTX1Manufactureraccessdata.fda.gov
ScrewdriverHXX1Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Contract manufacturer, Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufacturer, Manufactureraccessdata.fda.gov
Tray, SurgicalLRP1Manufactureraccessdata.fda.gov
Tray, Surgical, InstrumentFSM1Manufactureraccessdata.fda.gov
Trocar, EntKTE1Manufactureraccessdata.fda.gov
Twister, WireHXS1Manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 18, 2025K252281ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)IZQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
November 7, 2025K251295ulrichINJECT CT Motion (XD 8000)IZQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
August 26, 2024K241850ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)IZQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
April 19, 2024K233737ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)IZQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
August 6, 2021K210541ulrichINJECT CT motionIZQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
July 2, 2020K192872ulrichINJECT CT MotionIZQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
November 1, 2019K192117Small VBR™MQPSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
November 9, 2017K171392ulrichINJECT CT motionIZQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
December 22, 2016K161032neon3™ universal OCT spinal stabilizationNKGSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
December 14, 2015K150408V-STEADY, V-FASTLODSubstantially EquivalentG21, S.R.L.accessdata.fda.gov
September 24, 2015K150650neon3NKGSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
June 21, 2013K122957TEZO TITANIUM CAGE FAMILYMAXSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
March 4, 2013K123717UCENTUMNKBUnknownUlrich GmbH & Co. KGaccessdata.fda.gov
March 17, 2011K103814PEZO INTERBODY CAGES SYSTEMMAXSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
May 21, 2010K090861MAMBO, MODEL CS 18XX-XXKWQSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
October 5, 2009K090841ADDPLUSMQPSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
December 26, 2006K060416OBELISC VERTEBRAL BODY REPLACEMENT DEVICEMQPSubstantially EquivalentUlrich GmbH & Co. KGaccessdata.fda.gov
October 16, 2001K012254VBRMQPSubstantially EquivalentOsteotech, Inc.accessdata.fda.gov

Compare with other makers

Updated November 18, 2025. 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.