BONEBRIDGE AG

FDA Device Registration & Listing · ZUG, CH · Registration 3021010222

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
3021010222
FEI Number
3021010222
Entity Name
BONEBRIDGE AG
City/State/Country
ZUG, CH
Establishment Address
Bahnhofstrasse 11, ZUG 6300, CH
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Bonebridge AG (Owner Number: 10083420)
Owner / Operator Contact Address
Bahnhofstrasse 11, ZUG, CH-ZG 6300, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

K-Wires LORRAINE 2.5/3.5mm Distal Humerus System Bone Screw LE POYA 3.5mm Medial Proximal Tibia System SALTI 2.5/3.5mm Ankle System POYA 3.5mm Posteromedial Tibia System TAMINA 3.5mm Proximal Humerus System BRUSIO Trauma Toolbox System Power Tool TL Attachments Trays and racks POYA 3.5mm Lateral Proximal Tibia System TAMINA 3.5mm Proximal Humerus System LORRAINE 3.5mm Distal Humerus System Trial Implants POYA 3.5mm Proximal Tibia System SALGINA 2.5mm Distal Radius System CASCELLA 3.5mm Superior Clavicle System LEPORELLO 3.5mm Olecranon System Cortical Screws ø3.5mm L65mm - L90mm CASCELLA 3.5mm Superior Clavicle System DALVAZZA 2.5mm Distal Ulna System POYA 3.5mm Posteromedial Tibia System Variable Angle Locking Screws ø2.5mm L10mm - L30mm POYA 3.5mm Lateral Proximal Tibia System SALGINA 2.5mm Volar Distal Radius System LEPORELLO 3.5mm Olecranon System TAMINA 3.5mm Proximal Humerus System Cortical Screws ø2.5mm L10mm - L30mm Variable Angle Locking Screws ø3.5mm L10mm - L90mm Clamps

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 2022-09-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-06-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2025-06-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-11-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-12-18
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2022-09-21
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2022-09-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2023-07-21
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2023-07-21
HWT Template Orthopedic Class 1 888.4800 2022-09-21
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2026-04-27
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-09-20
HXD Clamp General, Plastic Surgery Class 1 878.4800 2022-09-21

Official Correspondent

Michelle Gumpelmayer M.Sc.

US Agent Details

Alfred Lerch Business: confinis USA Inc. Email: usagent@confinis.com Phone: (910) 2289391

Related Public Records

Same Entity

Bonebridge AG
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-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 3021010222. Last updated year: 2026. Please use registration number 3021010222 when referencing this establishment in official correspondence.
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