MERETE GMBH

FDA Device Registration & Listing · BERLIN, DE · Registration 3002949614

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
3002949614
FEI Number
3002949614
Entity Name
MERETE GMBH
City/State/Country
BERLIN, DE
Establishment Address
102 ALT LANKWITZ, BERLIN D-12247, DE
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
MERETE GMBH (Owner Number: 9048847)
Owner / Operator Contact Address
102 ALT LANKWITZ, --, BERLIN, DE-NOTA D-12247, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

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

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 2012-05-23
HTJ Gauge, Depth Orthopedic Class 1 888.4300 2005-08-25
FZY Hammer, Surgical General, Plastic Surgery Class 1 878.4800 2020-07-24
HTR Rasp General, Plastic Surgery Class 1 878.4800 2020-07-24
HWJ Awl Orthopedic Class 1 888.4540 2020-07-23
HXP Instrument, Bending Or Contouring Orthopedic Class 1 888.4540 2005-08-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2005-08-24
HXC Wrench Orthopedic Class 1 888.4540 2016-05-26
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2017-12-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-01
HWW Countersink Orthopedic Class 1 888.4540 2005-08-25
HTO Reamer Orthopedic Class 1 888.4540 2020-07-23
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2010-12-21
HXD Clamp General, Plastic Surgery Class 1 878.4800 2020-07-23
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2012-12-04
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2012-12-04
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2012-12-04
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2018-10-23
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2016-01-13
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2016-01-13
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2014-07-02
JYD Chisel, Mastoid General, Plastic Surgery Class 1 878.4800 2020-07-23
HXX Screwdriver Orthopedic Class 1 888.4540 2005-08-25
HWA Impactor Orthopedic Class 1 888.4540 2020-07-23
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-09-16
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2009-09-16
HWB Extractor Orthopedic Class 1 888.4540 2020-07-24
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2010-11-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-02-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2016-02-25
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2005-08-25
HTW Bit, Drill Orthopedic Class 1 888.4540 2005-08-25
HWT Template Orthopedic Class 1 888.4800 2016-08-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2009-09-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-04-10

Official Correspondent

Marc Kneissler

US Agent Details

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

Related Public Records

Same Entity

MERETE 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
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
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002949614. Last updated year: 2026. Please use registration number 3002949614 when referencing this establishment in official correspondence.
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