Ulrich GmbH & Co. KG
Dornstadt Baden-Wurttemberg, DE
ULRICH GMBH & CO. KG appears in FDA device records in Dornstadt Baden-Wurttemberg, DE. FDA records list 24 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 24 510(k) clearances for Ulrich GmbH & Co. KG between 2005 and 2025. The busiest year on record is 2011, with 3. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 1 |
| 2006 | 1 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2011 | 3 |
| 2012 | 2 |
| 2013 | 2 |
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2021 | 1 |
| 2024 | 2 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252281 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | IZQ | Substantially Equivalent | |
| K251295 | ulrichINJECT CT Motion (XD 8000) | IZQ | Substantially Equivalent | |
| K241850 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | IZQ | Substantially Equivalent | |
| K233737 | ulricheasyINJECT Max 2M (XD 10140); ulricheasyINJECT Max 3 (XD 10150); ulricheasyINJECT Max 3 (XD 10180) | IZQ | Substantially Equivalent | |
| K210541 | ulrichINJECT CT motion | IZQ | Substantially Equivalent | |
| K202227 | Artus™ cervical plate system | KWQ | Substantially Equivalent | |
| K192872 | ulrichINJECT CT Motion | IZQ | Substantially Equivalent | |
| K192117 | Small VBR™ | MQP | Substantially Equivalent | |
| K171392 | ulrichINJECT CT motion | IZQ | Substantially Equivalent | |
| K161032 | neon3™ universal OCT spinal stabilization | NKG | Substantially Equivalent | |
| K161723 | ulrich Transfer Set | PQH | Substantially Equivalent | |
| K150650 | neon3 | NKG | Substantially Equivalent | |
| K122957 | TEZO TITANIUM CAGE FAMILY | MAX | Substantially Equivalent | |
| K123717 | UCENTUM | NKB | Unknown | |
| K120891 | TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM | NKB | Substantially Equivalent | |
| K113346 | NEON SYSTEM | KWP | Substantially Equivalent | |
| K103814 | PEZO INTERBODY CAGES SYSTEM | MAX | Substantially Equivalent | |
| K101353 | GOLDEN GATE ANTERIOR PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K102853 | FLAMENCO SPINAL FIXATION SYSTEM | MNH | Substantially Equivalent | |
| K090861 | MAMBO, MODEL CS 18XX-XX | KWQ | Substantially Equivalent | |
| K090841 | ADDPLUS | MQP | Substantially Equivalent | |
| K080841 | COSMIC SYSTEM | MNI | Substantially Equivalent | |
| K060416 | OBELISC VERTEBRAL BODY REPLACEMENT DEVICE | MQP | Substantially Equivalent | |
| K052385 | TANGORS POLYAXIAL SYSTEM | NKB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3040111919 | 3040111919 | ULRICH GMBH & CO. KG | Lerchenbergstrasse 15, Dornstadt Baden-Wurttemberg 89160 DE | 2026 | |
| 9612420 | 3002807156 | ULRICH GMBH & CO. KG | BUCHBRUNNENWEG 12, ULM Baden-Wurttemberg D-89081 DE | 2026 | and 26 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- HWJAwl
- HTWBit, Drill
- LODBone Cement
- NDNCement, Bone, Vertebroplasty
- FZOChisel, Surgical, Manual
- GDJClamp, Surgical, General & Plastic Surgery
- FZSCurette, Surgical, General Use
- HTDForceps
- HTJGauge, Depth
- GDHGouge, Surgical, General & Plastic Surgery
- FZXGuide, Surgical, Instrument
- HXKHolder, Needle; Orthopedic
- GDGHook, Surgical, General & Plastic Surgery
- HWAImpactor
- IZQInjector, Contrast Medium, Automatic
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- PQHIodinated Contrast Media Transfer Tubing Set
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- MNIOrthosis, Spinal Pedicle Fixation
- MNHOrthosis, Spondylolisthesis Spinal Fixation
- NKGPosterior Cervical Screw System
- HXBProbe
- HXOPusher, Socket
- HTOReamer
- GADRetractor
- HTXRongeur
- HXXScrewdriver
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- NKBThoracolumbosacral Pedicle Screw System
- LRPTray, Surgical
- FSMTray, Surgical, Instrument
- KTETrocar, Ent
- HXSTwister, Wire
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain