Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612420

FEI Number

3002807156

Entity Name

ULRICH GMBH & CO. KG

City/State/Country

ULM Baden-Wurttemberg, DE

Establishment Address

BUCHBRUNNENWEG 12, ULM Baden-Wurttemberg D-89081, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ULRICH GMBH & CO. KG (Owner Number: 8010776)

Owner / Operator Contact Address

BUCHBRUNNENWEG 12, --, ULM, DE-BW D-89081, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

V-STEADY ULRICH DEPTH GAUGE ULRICH AWL obelisc ULRICH CHISEL neon3 tezo Titanium Cage Family ULRICH REAMER ULRICH ZIELKE RONGEUR ULRICH TRAY uNion® MAX Cervical Plate System ulrichINJECT CT motion ULRICH TROCAR Cortium AddPlus, Anterior Distraction Dev. small VBR HARMS IMPACTOR ULRICH IMPACTOR ULRICH HOOK Pusher, Socket Momentum Posterior Spinal Fixation System ULRICH JET TWISTER ULRICH SPREADER ULRICH INSTRUMENTS ULRICH CURETTE ulricheasyINJECT Max Small VBR pezo PEEK cage family ULRICH NEEDLEHOLDER ULRICH GUIDE ULRICH BIT, DRILL ULRICH CLAMP uCentum ULRICH USIS PROBE Momentum® MIS Posterior Spinal Fixation System ULRICH INSTRUMENT TRAY IMPLANT TRAY

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2021-12-10
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2021-12-10
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	1994-08-10
HWJ	Awl	Orthopedic	Class 1	888.4540	1994-08-10
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-12-04
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1994-08-10
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2015-10-05
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2015-10-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-06-27
HTO	Reamer	Orthopedic	Class 1	888.4540	2011-04-28
HTX	Rongeur	Orthopedic	Class 1	888.4540	1994-08-10
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2004-03-23
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2024-04-30
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2020-08-04
KTE	Trocar, Ent	Ear, Nose, Throat	Class 1	874.4420	2004-03-23
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2023-07-06
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2009-10-26
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2007-11-26
HWA	Impactor	Orthopedic	Class 1	888.4540	1994-08-10
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-03-23
HXO	Pusher, Socket	Orthopedic	Class 1	888.4540	2013-05-10
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-10-16
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	1994-08-10
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1994-08-10
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1994-08-10
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	1994-08-10
IZQ	Injector, Contrast Medium, Automatic	Cardiovascular	Class 2	870.1650	2024-09-02
PLR	Spinal Vertebral Body Replacement Device - Cervical	Orthopedic	Class 2	888.3060	2022-03-18
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2022-03-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2011-03-28
HXK	Holder, Needle; Orthopedic	Orthopedic	Class 1	888.4540	2009-04-08
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2004-03-23
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2004-03-23
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-03-23
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-03-06
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-03-06
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-03-06
HXB	Probe	Orthopedic	Class 1	888.4540	1994-08-10
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2023-11-29
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	1994-08-10

Official Correspondent

No official correspondent registered.

US Agent Details

Eric Gibbs Business: ULRICH MEDICAL USA, INC. Email: regulatory@ulrichmedicalusa.com Phone: (469) 2380832

Related Public Records

Same Entity

ULRICH GMBH & CO. KG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3040111919	ULRICH GMBH & CO. KG	Dornstadt Baden-Wurttemberg, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K041888	Signus Medizintechnik GmbH	CURVED PEEK TETRIS SPINAL IMPLANT	2004-08-10
K211892	Arftx Medical, LLC	ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)	2022-10-06
K070082	Vertebration,Inc	XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY	2007-04-20
K051027	Surgicraft , Ltd.	STALIF TT	2005-06-29
K963639	Acromed Corp.	ACROMED PEDICLE SCREW	1996-11-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0026-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011	Zimmer Inc.	2	SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011	Zimmer Inc.	2	SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

Similar Registrations

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9610726	HOWMEDICA INTERNATIONAL S. DE R.L.,	LIMERICK Munster, IE
1000461041	SELENIUM MEDICAL S.A.S.	La Rochelle Charente-Maritime, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612420. Last updated year: 2026. Please use registration number 9612420 when referencing this establishment in official correspondence.