Medical Device Manufacturer · DE , Ulm

Ulrich GmbH & Co. KG

24 submissions · 23 cleared · Since 2005
24
Total
23
Cleared
0
Denied

Ulrich GmbH & Co. KG — FDA 510(k) Submissions

Ulrich GmbH & Co. KG has submitted 24 FDA 510(k) premarket notifications since 2005, of which 23 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Injector, Contrast Medium, Automatic, Thoracolumbosacral Pedicle Screw System, Spinal Vertebral Body Replacement Device, Appliance, Fixation, Spinal Intervertebral Body, Intervertebral Fusion Device With Bone Graft, Lumbar . Use the specialty filter in the sidebar to narrow results.

24 devices
1–24 of 24
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
K252281 · IZQ Injector, Contrast... · General Hospital
Nov 2025 119d
ulrichINJECT CT Motion (XD 8000)
K251295 · IZQ Injector, Contrast... · General Hospital
Nov 2025 196d
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
K241850 · IZQ Injector, Contrast... · General Hospital
Aug 2024 60d
ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180)
K233737 · IZQ Injector, Contrast... · General Hospital
Apr 2024 149d
ulrichINJECT CT motion
K210541 · IZQ Injector, Contrast... · General Hospital
Aug 2021 163d
Artus? cervical plate system
K202227 · KWQ Appliance, Fixation,... · Orthopedic
Sep 2020 38d
ulrichINJECT CT Motion
K192872 · IZQ Injector, Contrast... · General Hospital
Jul 2020 268d
Small VBR?
K192117 · MQP Spinal Vertebral Body... · Orthopedic
Nov 2019 87d
ulrichINJECT CT motion
K171392 · IZQ Injector, Contrast... · Cardiovascular
Nov 2017 182d
neon3? universal OCT spinal stabilization
K161032 · NKG Posterior Cervical Screw... · Orthopedic
Dec 2016 253d
ulrich Transfer Set
K161723 · PQH Iodinated Contrast Media... · General Hospital
Dec 2016 182d
neon3
K150650 · NKG Posterior Cervical Screw... · Orthopedic
Sep 2015 196d
TEZO TITANIUM CAGE FAMILY
K122957 · MAX Intervertebral Fusion... · Orthopedic
Jun 2013 269d
UCENTUM
K123717 · NKB Thoracolumbosacral... · Orthopedic
Mar 2013 90d
TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM
K120891 · NKB Thoracolumbosacral... · Orthopedic
Oct 2012 192d
NEON SYSTEM
K113346 · KWP Appliance, Fixation,... · Orthopedic
Feb 2012 106d
PEZO INTERBODY CAGES SYSTEM
K103814 · MAX Intervertebral Fusion... · Orthopedic
Mar 2011 78d
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · KWQ Appliance, Fixation,... · Orthopedic
Feb 2011 266d
FLAMENCO SPINAL FIXATION SYSTEM
K102853 · MNH Orthosis,... · Orthopedic
Jan 2011 118d
MAMBO, MODEL CS 18XX-XX
K090861 · KWQ Appliance, Fixation,... · Orthopedic
May 2010 417d
ADDPLUS
K090841 · MQP Spinal Vertebral Body... · Orthopedic
Oct 2009 192d
COSMIC SYSTEM
K080841 · MNI Orthosis, Spinal Pedicle... · Orthopedic
Jul 2008 119d
OBELISC VERTEBRAL BODY REPLACEMENT DEVICE
K060416 · MQP Spinal Vertebral Body... · Orthopedic
Dec 2006 312d
TANGORS POLYAXIAL SYSTEM
K052385 · NKB Thoracolumbosacral... · Orthopedic
Dec 2005 119d
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