FDA.report

510(k) K253916

Device
APTUS Shoulder Proximal Humerus System, PentaLock 3.5
Applicant
Medartis AG
510(k) number
K253916
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-16
Date received
2025-12-08
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Salvatore Risoli
Address
Hochbergerstrasse 60e Basel CH 4057 4057

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code HRS

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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
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-03-17
K254053APS Spear Locking PlateA Plus Biotechnology Co., Ltd.2026-03-17
K253906Xpert HandNewclip Technics2026-03-11