HN AND M GMBH

FDA Device Registration & Listing · Derendingen Solothurn, CH · Registration 3010287687

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
3010287687
FEI Number
3010287687
Entity Name
HN AND M GMBH
City/State/Country
Derendingen Solothurn, CH
Establishment Address
Laengackerstrasse 2, Derendingen Solothurn 4552, CH
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
hn and m gmbh (Owner Number: 10043574)
Owner / Operator Contact Address
Laengackerstrasse 2, Derendingen, CH-SO 4552, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP HOWMEDICA OSTEONICS CORP

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-28
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2013-02-28
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2013-02-28
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-28
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-28
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2013-02-28
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2013-02-28
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-02-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-02-06
HWQ Passer Orthopedic Class 1 888.4540 2014-02-06
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-28
JEC Component, Traction, Invasive Orthopedic Class 2 888.3040 2013-02-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-02-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-28
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2014-02-06
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-28
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2016-04-23

Official Correspondent

Andreas Lanz

US Agent Details

Lance Johnson Business: LDJCG LLC Email: lance@ldjcg.com Phone: (512) 7757610

Related Public Records

Same Entity

hn and m 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
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
K202803 Newclip Technics Activmotion S DTO 2021-12-16
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08

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
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010287687. Last updated year: 2026. Please use registration number 3010287687 when referencing this establishment in official correspondence.
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