Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005290844

FEI Number

3005290844

Entity Name

DIENER AG PRECISION MACHINING

City/State/Country

Embrach Zurich, CH

Establishment Address

Stationsstrasse 66, Embrach Zurich 8424, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Diener AG Precision Machining (Owner Number: 10042488)

Owner / Operator Contact Address

Stationsstrasse 66, Embrach, CH-ZH 8424, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS 2.8 Depth Gauge Drill Guide Block, Right 2/2.3 Plate Holding&Positioning Instr. 2-2.3 Screwdriver Blade, HD6 2.2/3 Depth Gauge 2.2/3 Drill Stop for A-3738, A-3838 3.5/4 Depth Gauge Biconcave Washer 1.2/1.5 Plate Holding&Positioning Instr. Drill Guide Block, Left 2.5 Screwdriver Blade, HD7 Affixus Humerus Nail Portfolios NCB PLATING SYSTEM NCB Plating System NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2012-12-03
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2013-04-19
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-06-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-06-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-10-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-10-28
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2024-06-06
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2024-06-06
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2012-12-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2012-12-03

Official Correspondent

Andreas Miller

US Agent Details

Douglas Robinson Business: Diener Precision Pumps Inc Email: drobinson@dpp.swiss Phone: (209) 3650405

Related Public Records

Same Entity

Diener AG Precision Machining

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
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07

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.

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3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3009732568	BGS BETA-GAMMA-SERVICE GMBH & CO KG	Wiehl North Rhine-Westphalia, DE
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005290844. Last updated year: 2026. Please use registration number 3005290844 when referencing this establishment in official correspondence.