Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3024890263

FEI Number

3024890263

Entity Name

Zanol GmbH

City/State/Country

Neunkirch Schaffhausen, CH

Establishment Address

Langfeldweg 16, Neunkirch Schaffhausen 8213, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Zanol GmbH (Owner Number: 10086122)

Owner / Operator Contact Address

Langfeldweg 16, Neunkirch, CH-SH 8213, CH

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Trabecular Metal Acetabular Revision System Cage TRIFT 3.5mm 1/3 Tubular Plate, 3 Hole (B-210003) TRIFT 3.5mm 1/3 Tubular Plate, 13 Hole (B-210013) TRIFT 3.5mm 1/3 Tubular Plate, 11 Hole (B-210011) TRIFT 3.5mm 1/3 Tubular Plate, 5 Hole (B-210005) TRIFT 3.5mm 1/3 Tubular Plate, 9 Hole (B-210009) TRIFT 3.5mm 1/3 Tubular Plate, 7 Hole (B-210007)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2024-05-01
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-10-17

Official Correspondent

Jens Storz

US Agent Details

Alfred Lerch Business: confinis USA Inc. Email: usagent@confinis.com Phone: (910) 2289391

Related Public Records

Same Entity

Zanol 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
K860442	Howmedica Corp.	PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259	1986-05-06
K973124	Sulzer Orthopedics, Inc.	APR POROUS HA HIP SYSTEM	1997-11-03
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201

Similar Registrations

Registration Number	Establishment Name	Location
3012329926	UNITED ORTHOPEDIC CORPORATION	Hsinchu, TW
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
1526534	Sterigenics US, LLC	Lewis Center, OH, US
3020155054	SHALBY ADVANCED TECHNOLOGIES, INC.	El Dorado Hills, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3024890263. Last updated year: 2026. Please use registration number 3024890263 when referencing this establishment in official correspondence.