Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004450489

FEI Number

3004450489

Entity Name

HONER Medizin-Technik GmbH & Co. KG

City/State/Country

SPAICHINGEN Baden-Wurttemberg, DE

Establishment Address

Einsteinstr. 31, SPAICHINGEN Baden-Wurttemberg D-78549, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

HONER MEDIZIN-TECHNIK (Owner Number: 9060908)

Owner / Operator Contact Address

Einsteinstr. 31, SPAICHINGEN, DE-BW D-78549, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SAW BLADES (VARIOUS TYPES OF GENERA PLASTIC SURGERY SAW BLADES) Charriere Saw blade only MALLETS FOR GENERAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2004-02-02
HSO	Saw	General, Plastic Surgery	Class 1	878.4800	2013-03-01
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2017-07-25
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2011-07-18
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2018-07-23
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2012-12-21
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-03-01
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2011-07-18
HTX	Rongeur	Orthopedic	Class 1	888.4540	2011-07-18
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	2011-07-18
FAM	Sigmoidoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
GCF	Proctoscope	Gastroenterology, Urology	Class 2	876.1500	2024-12-16
GFA	Blade, Saw, General & Plastic Surgery, Surgical	General, Plastic Surgery	Class 1	878.4820	2004-02-02
LGG	Instrument, Cast Application/Removal, Manual	Orthopedic	Class 1	888.5980	2013-12-04
GFJ	Mallet, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2004-02-02
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-05-02
LRC	Instrument, Ent Manual Surgical	Ear, Nose, Throat	Class 1	874.4420	2012-12-21

Official Correspondent

TOBIAS HONER

US Agent Details

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

Related Public Records

Same Entity

HONER MEDIZIN-TECHNIK

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
K922626	Andronic Devices, Ltd.	ADEPT INSTRUMENT POSITIONING ACCESSORY	1992-10-19
K820290	The Anspach Effort, Inc.	SELF RETAINING RETRACTOR FOR HAND SURG	1982-03-05
K760422	Cutter Laboratories, Inc.	SURGICAL RETRACTOR	1976-08-23
K953012	Boston Surgical Products, Inc.	DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLS	1995-07-12
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12

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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3021574846	3D LOGICS LLC	Hillsboro, OR, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004450489. Last updated year: 2026. Please use registration number 3004450489 when referencing this establishment in official correspondence.