Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010303

FEI Number

4439

Entity Name

AUGUST REUCHLEN GMBH

City/State/Country

TUTTLINGEN Baden-Wurttemberg, DE

Establishment Address

JUNKERSSTRASSE 8, TUTTLINGEN Baden-Wurttemberg D-78532, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

AUGUST REUCHLEN GMBH (Owner Number: 8010303)

Owner / Operator Contact Address

JUNKERSSTRASSE 8, --, TUTTLINGEN, DE-BW D-78532, 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
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	1997-08-11
HWM	Osteotome	General, Plastic Surgery	Class 1	878.4800	1993-01-21
HAO	Instrument, Surgical, Non-Powered	Neurology	Class 1	882.4535	1997-08-11
GZQ	Instrument, Dowel Cutting	Neurology	Class 2	882.4275	2007-12-19
GZT	Retractor, Self-Retaining, For Neurosurgery	Neurology	Class 2	882.4800	2010-02-03
HCZ	Forceps, Surgical, Gynecological	Obstetrics/Gynecology	Class 2	884.4530	2007-12-19
HDA	Forceps, Obstetrical	Obstetrics/Gynecology	Class 2	884.4400	2007-12-19
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	1997-03-06
HBG	Drills, Burrs, Trephines & Accessories (Manual)	Neurology	Class 2	882.4300	2007-12-19
GAD	Retractor	General, Plastic Surgery	Class 1	878.4800	1997-08-11
EIG	Retractor, All Types	Dental	Class 1	872.4565	1989-12-11

Official Correspondent

ALICE GAISELMANN

US Agent Details

Robert Ucman Email: ucmanr@gmail.com Phone: (719) 6239366

Related Public Records

Same Entity

AUGUST REUCHLEN GMBH

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-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

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3021574846	3D LOGICS LLC	Hillsboro, OR, US
3030089866	ORTOLOG MEDIKAL SANAYI VE TICARET A.S.	Yenimahalle Ankara, TR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010303. Last updated year: 2026. Please use registration number 8010303 when referencing this establishment in official correspondence.