Aristotech Industries GmbH

FDA Device Registration & Listing · Berlin, DE · Registration 3014314623

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
3014314623
FEI Number
3014314623
Entity Name
Aristotech Industries GmbH
City/State/Country
Berlin, DE
Establishment Address
Alt-Lankwitz 102, Berlin 12447, 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

OsteoBridge" IKA Knee Arthrodesis Torque Limiter T-Handle Wirefix Retractor MetaStep" Saw Template OsteoBridge" Trocar OsteoBridge" IKA Knee Arthrodesis Cement Protection Cap MetaStep" Stamp Various handles with ratchet Rasp Handle MetaStep" Steinmann Nail Chronoceptor" OsteoBridge" IKA Knee Arthrodesis Distance Holder MetaStep" Positioning Screw MetaStep" Displacement Device OsteoBridge" IDSF System Implants for Humerus, Tibia and Femur: Nails, Spacers, Connectors, Interlocking Screws Merete Style 2 Locking Bone Plate (MTP Plate) Tissue Protector OsteoBridge" Drill Sleeve Double Drill Sleeve OsteoBridge" Protection Sleeve OsteoBridge Drill Sleeve OsteoBridge" IKA Knee Arthrodesis Guiding Pin OsteoBridge" IKA Nail Guiding Impacting/Instrument PediatrOS" FlexTack"/RigidTack" Target device MetaFix" I Drill Guide K-Wire PediatrOS" FlexTack" Staples (20 mm, 25 mm and 30 mm) PediatrOS" RigidTack" Staples (20 mm, 25 mm and 30 mm) Merete Locking Screws dia 3 and 3.5 mm Ludloff Osteotomy Fixation Clamp Bone Clamp for Scarf Osteotomie OsteoBridge" IDSF Diaphysis Spacer Clamp MetaFix" LS Locking Screws Merete Cannulated HCS Merete CS Cortical Screws Merete Cannulated PCS TwistCut" Snap-Off Screws TwistCut" Snap-Off Screw OsteoBridge" IKA Knee Arthrodesis Impactor PediatrOS" FlexTack"/RigidTack" Impactor Bending Instrument OsteoBridge" IKA Knee Arthrodesis Trial Nail 3D-Saw Template for Scarf/Chevron Osteotomie OsteoBridge" IDSF Diaphysis Trial Nail OsteoBridge" IDSF Diaphysis Spacer Gauge Merete Style 13 Locking Bone Plate III (MetaStep" Calcaneus Plate) Merete Cannulated PCS Plate Compression Screw Merete Style 10 Locking Bone Plate III (MetaFix" Plantar BG10 Plate) Merete CS Cortical Screw dia 3.5 mm fully / short threaded Merete Style 12 Locking Bone Plate III (MetaFix" I Plate) K-Wires Merete Style 11 Locking Bone Plate III (MetaFix" PlantarMAX" Plate) Merete CS Cortical Screw dia 3 mm fully / short threaded MetaFix" LS Locking Screw dia 3.5 mm MultiCup" Joint Screw Driver OsteoBridge" IKA Knee Arthrodesis Screwdriver OsteoBridge" Screwdriver Various screwdrivers for foot surgeries OsteoBridge" Drill MultiCup" Joint Drill Bit Various Drills for Foot Surgery (Twist Drill, Over-Drill, Drill Bit) Tap Various Depth Gauges for Foot Surgery and OsteoBridge Rasp for bone preparation STERILIZING CASE STORAGE Steel Ruler BONE SCREW RULER PediatrOS" FlexTack"/RigidTack" Chisel MetaCun" II Plate Merete Style 6 Locking Bone Plate II (Open Wedge" Plate) DuoMetaCun" II Plate PediatrOS" FlexTack"/RigidTack" K-wire grip Various Wrenches for orthopedic procedures OsteoBridge IKA Knee Arthrodesis 10 Spacer OsteoBridge IKA Knee Arthrodesis Nail without Collar OsteoBridge IKA Knee Arthrodesis Nail with Collar OsteoBridge Interlocking Screw OsteoBridge" IKA Knee Arthrodesis Manual Awl Merete Compression Screws dia 3, 4.3 and 6.5 mm Merete CS Cortical Screw dia 3.5 mm fully threaded Merete CS Cortical Screw dia 3 mm short threaded Merete CS Cortical Screw dia 3 mm, fully threaded Merete CS Cortical Screw dia 3.5 mm short threaded PediatrOS" FlexTack"/RigidTack" Extractor OsteoBridge" Extractor Screw Extractor for cannulated Screws BONE SCREW COUNTERSINK

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 2018-01-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-10-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-01-24
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2016-12-19
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2018-01-24
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-24
HXD Clamp General, Plastic Surgery Class 1 878.4800 2020-07-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-23
HWA Impactor Orthopedic Class 1 888.4540 2020-07-27
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2018-01-23
HWT Template Orthopedic Class 1 888.4800 2018-01-23
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2018-01-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2018-01-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-23
HXX Screwdriver Orthopedic Class 1 888.4540 2018-01-23
HTW Bit, Drill Orthopedic Class 1 888.4540 2018-01-23
HWX Tap, Bone Orthopedic Class 1 888.4540 2020-07-27
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2018-01-23
HTR Rasp General, Plastic Surgery Class 1 878.4800 2020-07-27
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2018-01-23
FTY Tape, Measuring, Rulers And Calipers General, Plastic Surgery Class 1 878.4800 2018-01-23
JYD Chisel, Mastoid General, Plastic Surgery Class 1 878.4800 2020-07-27
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2018-01-23
HXC Wrench Orthopedic Class 1 888.4540 2018-01-23
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-01-23
HWJ Awl Orthopedic Class 1 888.4540 2020-07-27
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-24
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2018-01-23
HWB Extractor Orthopedic Class 1 888.4540 2020-07-27
HWW Countersink Orthopedic Class 1 888.4540 2018-01-23

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
3010206549 ARISTOTECH INDUSTRIES GMBH Luckenwalde Brandenburg, DE

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
K033476 Howmedica Osteonics Corp. MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM 2004-01-20

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014314623. Last updated year: 2026. Please use registration number 3014314623 when referencing this establishment in official correspondence.
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