Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611274

FEI Number

3002808043

Entity Name

RUDOLF STORZ GMBH

City/State/Country

EMMINGEN Baden-Wurttemberg, DE

Establishment Address

FRIEDRICH-WOEHLER-STR. 13, EMMINGEN Baden-Wurttemberg D-78576, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

RUDOLF STORZ GMBH (Owner Number: 8010286)

Owner / Operator Contact Address

FRIEDRICH-WOEHLER-STR.13, --, EMMINGEN, DE-BW 78576, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

T2 ICF System Retractor, Surgical, General & Plastic Surgery 06-60-1010

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FZR	Contractor, Surgical	General, Plastic Surgery	Class 1	878.4800	2000-04-11
KAE	Forceps, Ent	Ear, Nose, Throat	Class 1	874.4420	2013-01-15
KCA	Tonsillectome	Ear, Nose, Throat	Class 1	874.4420	2020-11-23
HXY	Brace, Drill	Orthopedic	Class 1	888.4540	2011-01-31
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2007-11-22
GWM	Device, Monitoring, Intracranial Pressure	Neurology	Class 2	882.1620	2013-02-14
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2012-09-18
FFQ	Speculum, Rectal	Gastroenterology, Urology	Class 1	876.4730	2013-02-03
HAX	Tong, Skull For Traction	Neurology	Class 2	882.5960	2008-03-06
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2013-03-07
EYR	Tourniquet, Gastro-Urology	General, Plastic Surgery	Class 1	878.5900	2020-11-23
GAC	Rasp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1986-06-02
EMI	File, Bone, Surgical	Dental	Class 1	872.4565	2013-03-07
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2006-04-18
FFY	Adaptor, Bulbs, Miscellaneous, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2018-05-08
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2012-12-29
HDL	Retractor, Vaginal	Obstetrics/Gynecology	Class 1	884.4520	2011-06-22
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2001-04-13
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1978-06-02
EMH	Forceps, Rongeur, Surgical	Dental	Class 1	872.4565	2013-02-25
KBZ	Snare, Tonsil	Ear, Nose, Throat	Class 1	874.4420	2020-11-23
HTR	Rasp	General, Plastic Surgery	Class 1	878.4800	2013-02-03
EIL	Gauge, Depth, Instrument, Dental	Dental	Class 1	872.4565	2021-06-29
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	1998-01-05
HOE	Caliper, Ophthalmic	Ophthalmic	Class 1	886.4350	2015-11-12
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	1998-01-05
KDG	Chisel (Osteotome)	General, Plastic Surgery	Class 1	878.4820	1986-06-02
EKE	Curette, Operative	Dental	Class 1	872.4565	1998-01-05
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1986-06-05
HXS	Twister, Wire	Orthopedic	Class 1	888.4540	2000-04-11
FHL	Scoop	Gastroenterology, Urology	Class 1	876.4730	1986-06-02
HXG	Tamp	Orthopedic	Class 1	888.4540	2013-02-07
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-11-27
HWT	Template	Orthopedic	Class 1	888.4800	2022-07-13
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2020-11-23
KTZ	Caliper	Orthopedic	Class 1	888.4150	2000-04-11
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2017-06-15
HXE	Fork	Orthopedic	Class 1	888.4540	2016-11-22
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2018-11-15
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2014-07-04
FZS	Curette, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2010-03-05
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2007-01-24
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1986-06-02
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-09-13
GFI	Osteotome, Manual	General, Plastic Surgery	Class 1	878.4800	2013-02-03
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-12-18
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-12-18
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-12-18
HTE	Elevator	General, Plastic Surgery	Class 1	878.4800	2013-02-03
GXM	Anvil, Skull Plate	Neurology	Class 1	882.4030	1998-01-05
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2020-06-30
JXG	Shunt, Central Nervous System And Components	Neurology	Class 2	882.5550	2013-02-14
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2013-02-27
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1986-06-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2017-10-26
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	1986-06-02
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2000-04-11
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2007-01-24
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2008-03-06
GDI	Dissector, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-02-03
HBO	Clip, Scalp	Neurology	Class 2	882.4150	2007-11-22
KBN	Gag, Mouth	Ear, Nose, Throat	Class 1	874.4420	2013-02-06
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2003-03-17
KAL	Retractor, Ent	Ear, Nose, Throat	Class 1	874.4420	2010-03-05
HWB	Extractor	Orthopedic	Class 1	888.4540	2013-02-25
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	1998-01-05
HRT	Stripper, Surgical	Orthopedic	Class 1	888.4540	2013-02-27
GDG	Hook, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	1978-06-02
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2010-09-13
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2007-06-07
FZO	Chisel, Surgical, Manual	General, Plastic Surgery	Class 1	878.4800	1998-01-05
HTZ	Instrument, Cutting, Orthopedic	General, Plastic Surgery	Class 1	878.4800	2010-04-19
HBD	Handpiece (Brace), Drill	Neurology	Class 1	882.4325	2000-10-31
FZY	Hammer, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-02-07
EXX	Probe, Rectal, Non-Powered	Gastroenterology, Urology	Class 1	876.4730	2013-02-07
HTS	Knife, Orthopedic	Orthopedic	Class 1	888.4540	1986-06-05
KAI	Mirror, Ent	Ear, Nose, Throat	Class 1	874.4420	2011-02-17
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2013-03-07
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2007-11-22
HTF	Curette	General, Plastic Surgery	Class 1	878.4800	1986-06-02
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2013-03-07
JDW	Pin, Fixation, Threaded	Orthopedic	Class 2	888.3040	2013-03-07
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2013-03-07
FCW	Light Source, Fiberoptic, Routine	Gastroenterology, Urology	Class 2	876.1500	2016-02-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-09-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-09-19

Official Correspondent

No official correspondent registered.

US Agent Details

Franz Menean Business: MEDAGENT Inc. Email: mail@medagent-usa.com Phone: (603) 5702039

Related Public Records

Same Entity

RUDOLF STORZ GMBH

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K020558	Integra Neurosciences	LICOX CC1.G2 BRAIN OXYGEN CATHETER-MICROPROBE	2002-03-21
K243425	Talladium España, SL	Guided DAS Surgical Kit	2025-07-22
K213209	K1 Medical, LLC	EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device	2021-12-28
K012105	Symmetry Medical, Inc.	POLYVAC SURGICAL INSTRUMENT DELIVERY SYSTEM	2002-08-02
K243317	Infinitum Eta, Ltd.	NUVENTUS NV.C Surgical Cassette and Tray	2025-02-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2007	Smith & Nephew Inc	1	Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007	Smith & Nephew Inc	1	Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06	Stryker Howmedica Osteonics Corp.	1	Allocraft TLIF Bone Inserter.
Z-0011-2007	Smith & Nephew Inc	1	Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

Registration Number	Establishment Name	Location
9680735	HERMANN MUELLER Medizintechnik GmbH	TUTTLINGEN Baden-Wurttemberg, DE
3012226300	AVILIGN MEDICAL	Sialkot Punjab, PK
3007773213	SITEC (PVT.) LTD.	SIALKOT Punjab, PK
9612278	DUFNER INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611274. Last updated year: 2026. Please use registration number 9611274 when referencing this establishment in official correspondence.