Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010405

FEI Number

4442

Entity Name

JOSEF BETZLER SURGICAL INSTRUMENTS e.K.

City/State/Country

SEITINGEN Baden-Wurttemberg, DE

Establishment Address

HOHNERSTR. 15, SEITINGEN Baden-Wurttemberg 78606, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

JOSEF BETZLER SURGICAL INSTRUMENTS e.K. (Owner Number: 8010405)

Owner / Operator Contact Address

HOHNERSTR. 15, --, SEITINGEN, DE-NOTA 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
HWN	Instrument, Compression	Orthopedic	Class 1	888.4540	2015-05-19
KBA	Rasp, Nasal	Ear, Nose, Throat	Class 1	874.4420	2010-03-16
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	2006-07-26
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-05-18
FFO	Retractor, Self-Retaining	Gastroenterology, Urology	Class 1	876.4730	1978-03-31
DWS	Instruments, Surgical, Cardiovascular	Cardiovascular	Class 1	870.4500	2015-01-14
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2012-12-03

Official Correspondent

TOBIAS BETZLER

US Agent Details

ANGELIKA SCHERP Business: BUSINESS SUPPORT INTERNATIONAL Email: INFO@BSI-FDA.COM Phone: (212) 3318358

Related Public Records

Same Entity

JOSEF BETZLER SURGICAL INSTRUMENTS e.K.

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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2014	Aesculap, Inc.	1	UNITRAC Pneumatic Retraction Arm. A support arm used to hold surgical instruments during surgical procedures.
Z-0008-04	Rultract Inc	1	Rultract Surgical Retractor, 4100 Series, all system configurations, reusable.

Similar Registrations

Registration Number	Establishment Name	Location
1064129	Orthopedic Designs North America, Inc.	Tampa, FL, US
3009158523	NEOORTHO PRODUTOS ORTOPEDICOS S/A	Curitiba Parana, BR
3006639944	SHANDONG WEIGAO ORTHOPAEDIC DEVICE CO.,LTD	weihai Shandong, CN
3009554293	CG MedTech USA, Inc.	Irvine, CA, US
3008812560	Synthes (USA) Products LLC	West Chester, PA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010405. Last updated year: 2026. Please use registration number 8010405 when referencing this establishment in official correspondence.