STORK INSTRUMENTE GMBH

FDA Device Registration & Listing · Emmingen-Liptingen Baden-Wurttemberg, DE · Registration 8010547

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
8010547
FEI Number
1000168975
Entity Name
STORK INSTRUMENTE GMBH
City/State/Country
Emmingen-Liptingen Baden-Wurttemberg, DE
Establishment Address
ENGENERSTR. 29, Emmingen-Liptingen Baden-Wurttemberg 78576, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
STORK INSTRUMENTE GMBH (Owner Number: 8010547)
Owner / Operator Contact Address
ENGENERSTR. 29, --, EMMINGEN-LIPTINGEN 1, DE-BW 78576, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EPY Speculum, Ent General, Plastic Surgery Class 1 878.1800 1985-06-18
KQW Goniometer, Nonpowered Orthopedic Class 1 888.1520 1998-01-09
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2013-01-31
KIK Hook, Bone General, Plastic Surgery Class 1 878.4800 1998-01-09
HCF Instrument, Ligature Passing And Knot Tying General, Plastic Surgery Class 1 878.4800 1983-09-27
GEN Forceps, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1985-06-18
HNI Retractor, Ophthalmic Ophthalmic Class 1 886.4350 2012-12-13
EMK Curette, Surgical, Dental Dental Class 1 872.4565 1985-06-18
HWT Template Orthopedic Class 1 888.4800 1998-01-09
GAF Spatula, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1986-05-15
HWB Extractor Orthopedic Class 1 888.4540 1998-01-09
GZX Instrument, Microsurgical Neurology Class 1 882.4525 2012-12-13
FGM Probe And Director, Gastro-Urology Gastroenterology, Urology Class 1 876.4730 1986-05-15
KAL Retractor, Ent Ear, Nose, Throat Class 1 874.4420 2012-12-13
GDG Hook, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1985-06-18
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 1998-01-09
HWJ Awl Orthopedic Class 1 888.4540 1997-09-09
HRT Stripper, Surgical Orthopedic Class 1 888.4540 1998-01-09
FZO Chisel, Surgical, Manual General, Plastic Surgery Class 1 878.4800 2013-11-14
GEG Elevator, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1985-06-18
GAC Rasp, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1997-07-11
LRC Instrument, Ent Manual Surgical Ear, Nose, Throat Class 1 874.4420 2013-01-31
EMI File, Bone, Surgical Dental Class 1 872.4565 1998-01-09
KAJ Mobilizer, Ent Ear, Nose, Throat Class 1 874.4420 1998-01-09
FZS Curette, Surgical, General Use General, Plastic Surgery Class 1 878.4800 2012-12-13
GFI Osteotome, Manual General, Plastic Surgery Class 1 878.4800 1997-06-25
FMA Depressor, Tongue, Non-Surgical General Hospital Class 1 880.6230 1998-01-09
EMM Chisel, Osteotome, Surgical Dental Class 1 872.4565 1985-06-18
KAD Elevator, Ent Ear, Nose, Throat Class 1 874.4420 2012-12-13
HDF Speculum, Vaginal, Metal Obstetrics/Gynecology Class 1 884.4520 1986-05-15
GAD Retractor General, Plastic Surgery Class 1 878.4800 1985-06-18
HXI Passer, Wire, Orthopedic Orthopedic Class 1 888.4540 1998-01-09
HNM Needle, Ophthalmic Suturing Ophthalmic Class 1 886.4350 1983-09-27
GDH Gouge, Surgical, General & Plastic Surgery General, Plastic Surgery Class 1 878.4800 1998-01-09

Official Correspondent

Klaus Stoerk

US Agent Details

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

Related Public Records

Same Entity

STORK INSTRUMENTE 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
K834189 Imm Enterprises , Ltd. JAKOBI SURG. INSTRUMENTS #7 44/47 1984-03-06
K851170 The Huxley Instrument Corp. DISSECTING TWEEZER #283-72PCS. SS 410 1985-04-25
K821248 Conphar, Inc. ROCHESTER PEAN FORCEPS 1982-05-28
K143738 Intuit Medical Products, LLC DSS Sinusplasty Balloon Catheter 2015-08-27
K922626 Andronic Devices, Ltd. ADEPT INSTRUMENT POSITIONING ACCESSORY 1992-10-19

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010547. Last updated year: 2026. Please use registration number 8010547 when referencing this establishment in official correspondence.
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