Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009547284

FEI Number

3009547284

Entity Name

MEDIZINTECHNIK SATTLER GMBH

City/State/Country

Koenigsee Thuringia, DE

Establishment Address

Werkstrasse 9, Koenigsee Thuringia 07426, DE

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Medizintechnik Sattler GmbH (Owner Number: 10040331)

Owner / Operator Contact Address

Werkstrasse 9, Koenigsee, DE-TH 07426, 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	2016-06-30
HWX	Tap, Bone	Orthopedic	Class 1	888.4540	2012-04-02
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2023-02-14
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2012-04-02
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2012-04-02
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2013-11-08
GDF	Guide, Needle, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-06-06

Official Correspondent

Danny Sattler

US Agent Details

Beate Weiss-Krull Business: Beate Weiss-Krull, Attorney at Law Email: bea@weisskrull-law.com Phone: (503) 2340355

Related Public Records

Same Entity

Medizintechnik Sattler 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-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 3009547284. Last updated year: 2026. Please use registration number 3009547284 when referencing this establishment in official correspondence.