Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9611815

FEI Number

3002808483

Entity Name

WEINMANN GMBH CHIRURGISCHE INSTRUMENTE

City/State/Country

SEITINGEN-OBERFLACHT Baden-Wurttemberg, DE

Establishment Address

Hohnerstr. 31, SEITINGEN-OBERFLACHT Baden-Wurttemberg D-78606, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

WEINMANN GMBH CHIRURGISCHE INSTRUMENTE (Owner Number: 8010280)

Owner / Operator Contact Address

Hohnerstr. 31, --, SEITINGEN-OBERFLACHT, DE-BW 78606, DE

Initial Importer Flag

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
HFB	Forceps, Biopsy, Gynecological	Obstetrics/Gynecology	Class 1	884.4530	1998-02-26
HTX	Rongeur	Orthopedic	Class 1	888.4540	2013-04-14
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-01-27
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	2003-05-30
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2003-05-30
LRY	Punch, Surgical	General, Plastic Surgery	Class 1	878.4800	2013-04-14

Official Correspondent

HARALD WEINMANN

US Agent Details

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

Related Public Records

Same Entity

WEINMANN GMBH CHIRURGISCHE INSTRUMENTE

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

View Entity Profile →

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
8010251	HBH MEDIZINTECHNIK GMBH	TUTTLINGEN Baden-Wurttemberg, DE
3035708926	MED2B LTD.	Kitzingen Bavaria, DE
3035678069	MATTES INSTRUMENTE GMBH	Tuttlingen-Nendingen Baden-Wurttemberg, DE
8010704	NOPA INSTRUMENTS, MEDIZINTECHNIK GMBH	TUTTLINGEN Baden-Wurttemberg, DE
9612086	B. BRAUN MEDICAL INDUSTRIES SDN. BHD.	PENANG Pulau Pinang, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9611815. Last updated year: 2026. Please use registration number 9611815 when referencing this establishment in official correspondence.