Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012439458

FEI Number

3012439458

Entity Name

Mathys AG Bettlach

City/State/Country

Bettlach Solothurn, CH

Establishment Address

Robert Mathys Strasse 5, Bettlach Solothurn 2544, CH

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ENCORE MEDICAL, L.P. (Owner Number: 9002203)

Owner / Operator Contact Address

9800 METRIC BLVD., --, Austin, TX 78758, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

ceramys femoral head system

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2025-02-26

Official Correspondent

Sherri Mellingen

US Agent Details

Sherri Mellingen Business: ENCORE MEDICAL, L.P. Email: sherri.mellingen@enovis.com Phone: (952) 9136383

Related Public Records

Same Entity

ENCORE MEDICAL, L.P.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3036795922	Mathys Orthopaedie GmbH	Moersdorf Thuringia, DE
1644408	ENCORE MEDICAL, L.P.	AUSTIN, TX, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Similar Registrations

Registration Number	Establishment Name	Location
3021386586	LINCOTEK (WUXI) CO., LTD.	Wuxi Jiangsu, CN
3005061536	SYMMETRY MEDICAL MANUFACTURING INC	CLAYPOOL, IN, US
3007923096	Changzhou Biomet Medical Devices Co., Ltd.	Changzhou City Jiangsu, CN
3005562917	BGS Beta-Gamma-Service GmbH & Co KG	Bruchsal Baden-Wurttemberg, DE
1450662	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012439458. Last updated year: 2026. Please use registration number 3012439458 when referencing this establishment in official correspondence.