Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000649241

FEI Number

1000649241

Entity Name

Bort GmbH

City/State/Country

WEINSTADT-BENZACH Baden-Wurttemberg, DE

Establishment Address

Am Schweizerbach 1, WEINSTADT-BENZACH Baden-Wurttemberg 71384, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

BORT GMBH (Owner Number: 9063519)

Owner / Operator Contact Address

Am Schweizerbach 1, Weinstadt-Benzach, DE-BW 71384, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL Bort Medical BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL Bort Medical Bort Medical BORT MEDICAL BORT MEDICAL BORT MEDICAL BORT MEDICAL

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KQZ	Component, Traction, Non-Invasive	Orthopedic	Class 1	888.5890	2015-02-23
KIC	Cushion, Flotation	Physical Medicine	Class 1	890.3175	2008-02-01
EXN	Support, Hernia	Gastroenterology, Urology	Class 1	876.5970	2008-02-01
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2008-02-01
KTD	Orthosis, Abdominal	Physical Medicine	Class 1	890.3490	2015-02-24
KYS	Insoles, Medical	General Hospital	Class 1	880.6280	2015-02-23
ITM	Cage, Knee	Physical Medicine	Class 1	890.3475	2008-02-01
IQE	Orthosis, Lumbar	Physical Medicine	Class 1	890.3490	2008-02-01
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2022-12-07
ITS	Joint, Hip, External Brace	Physical Medicine	Class 1	890.3475	2015-02-23
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2008-02-01
IQK	Orthosis, Cervical	Physical Medicine	Class 1	890.3490	2015-03-26
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2015-02-23
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2004-06-02
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2022-12-13
DWL	Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)	General Hospital	Class 2	880.5780	2022-12-07
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2004-06-22
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2015-04-13
IQI	Orthosis, Limb Brace	Physical Medicine	Class 1	890.3475	2004-05-14
IPT	Orthosis, Thoracic	Physical Medicine	Class 1	890.3490	2004-06-22

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: david.lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

BORT GMBH

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-0006-2025	Ossur H F Grjothals 5 Reykjavik Iceland	1	Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: MJSR-101
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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3011715925	MAQ-OPS S. de R.L.	Tijuana Baja California, MX
2921578	MIZUHO ORTHOPEDIC SYSTEMS, INC.	UNION CITY, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000649241. Last updated year: 2026. Please use registration number 1000649241 when referencing this establishment in official correspondence.