Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011404939

FEI Number

3011404939

Entity Name

FIOR AND GENTZ GMBH

City/State/Country

Lueneburg Lower Saxony, DE

Establishment Address

Dorette-von-Stern-Strasse 5, Lueneburg Lower Saxony 21337, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fior & Gentz Gesellschaft fuer Entwicklung und Vertrieb von (Owner Number: 10050337)

Owner / Operator Contact Address

Dorette-von-Stern-Strasse 5, Lüneburg, DE-NI 21337, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Madrid Frankfurt Erfurt Standard Hamburg Stendal Kopenhagen Augsburg Breit Flensburg Standard Mailand Stuttgart Erfurt Breit Amsterdam Wetzlar Kassel Breit Muenchen Wuppertal Nuernberg Breit Augsburg Standard London Bremen Nuernberg Standard Stockholm Heidelberg Dresden Breit Leipzig Hannover Kassel Standard Freiburg Koeln Konstanz Berlin Dresden Standard Regensburg NEURO SWING FIT AFO Service Fabrication AFO/KAFO NEURO HiTRONIC NEURO LOCK NEURO CLASSIC zero NEURO CLASSIC NEURO FLEX MAX (step lock function) NEURO LOCK MAX NEURO CLASSIC Carbon NEURO VARIO-SWING NEURO MATIC NEURO VARIO zero NEURO VARIO 2 NEURO VARIO NEURO ACTIVE (system side bar) NEURO ACTIVE (system joint) NEURO TRONIC NEURO LOCK Carbon NEURO FLEX MAX (lock function) CROSSROADS schwarz CITYDRIVE PARKSTREET URBANSTREET CROSSROADS braun NEURO HiSWING NEURO SWING 2 NEURO CLASSIC Carbon NEURO SWING Carbon NEURO VARIO-CLASSIC NEURO CLASSIC NEURO SWING-CLASSIC NEURO CLASSIC-SPRING NEURO VARIO-SWING NEURO VARIO-SPRING NEURO SWING NEURO CLASSIC-SWING NEURO VARIO-SPRING 2 NEURO VARIO NEURO HiSWING R+ NEURO VARIO-CLASSIC 2 NEURO VARIO 2

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2024-08-29
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2015-11-05
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2023-07-25
QDT	Shoe With Adjustable Sole Units	Physical Medicine	Class 1	890.3475	2024-08-29
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2023-07-25

Official Correspondent

Thomas Gast

US Agent Details

Katla Axelsdottir Business: Ossur Email: Kaxelsdottir@Ossur.com Phone: (949) 3823833

Related Public Records

Same Entity

Fior & Gentz Gesellschaft fuer Entwicklung und Vertrieb von

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011404939. Last updated year: 2026. Please use registration number 3011404939 when referencing this establishment in official correspondence.