ARISTOTECH INDUSTRIES GMBH

FDA Device Registration & Listing · Luckenwalde Brandenburg, DE · Registration 3010206549

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3010206549
FEI Number
3010206549
Entity Name
ARISTOTECH INDUSTRIES GMBH
City/State/Country
Luckenwalde Brandenburg, DE
Establishment Address
Im Biotechnologiepark, Luckenwalde Brandenburg 14943, DE
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Aristotech Industries GmbH (Owner Number: 10053573)
Owner / Operator Contact Address
Im Biotechnologiepark, Luckenwalde, DE-BB 14943, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Z1 Hip 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 2024-07-16
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2024-07-16
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2024-07-16
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2024-07-16
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2024-07-16

Official Correspondent

Jens-Erik Wegner

US Agent Details

Marc Kneissler Email: mkneissler@merete-medical.com Phone: (630) 6137181

Related Public Records

Same Entity

Aristotech Industries GmbH
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014314623 Aristotech Industries GmbH Berlin, DE

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

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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 3010206549. Last updated year: 2026. Please use registration number 3010206549 when referencing this establishment in official correspondence.
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