FDA.reportPublic FDA data

510(k) K243308

Device
Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste)
Applicant
Bonebridge AG
510(k) number
K243308
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2024-12-20
Date received
2024-10-21
Regulation
888.3030
Classification name
Plate, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Michelle Gumpelmayer
Address
Bahnhofstrasse 11 Zug CH 6300 6300

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HRS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260761APTUS Clavicle System 2.8Medartis AG2026-06-05
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K261038Xpert PFPNewclip Technics2026-05-29
K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026-05-09
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K260411PC Fix SystemChest Wall Innovations, Inc.2026-04-24
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG2026-04-24
K260054I.T.S. PRS Phoenix III.T.S. GmbH2026-04-24
K260090SMART Osteotomy SystemActis Medical Pty., Ltd.2026-04-10
K253718enHAnce PEEK Bunion SystemNvision Biomedical Technologies, Inc.2026-04-01
K260291Vortex5 Tailor's Bunion Correction SystemNvision Biomedical Technologies, Inc.2026-03-25
K260274Airlock® Ankle Plating SystemNovastep SAS2026-03-25
K254253LOQTEQ® VA Proximal Humerus Plate 3.5Aap Implantate AG2026-03-24
K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.2026-03-23
K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.2026-03-19