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510(k) K193639

Device
APTUS® Foot 2.8-3.5 System
Applicant
Medartis AG
510(k) number
K193639
Product code
HRS  
Decision
Substantially Equivalent (SESE)
Decision date
2020-03-26
Date received
2019-12-27
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
Andrea Kiefer-Schweizer
Address
Hochbergerstrasse 60e Basel-Stadt CH CH-4057 CH-4057

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
K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi2026-08-28
K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-08-19
K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.2026-08-13
K261511Xpert AnkleNewclip Technics2026-07-28
K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-07-21
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.2026-07-16
K261191Alians Elbow SNewclip Technics2026-07-08
K261054RibPlate SystemStryker Leibinger GmbH & Co KG2026-07-01
K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG2026-06-26
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LI.T.S. GmbH2026-06-16
K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026-06-12
K260761APTUS Clavicle System 2.8Medartis AG2026-06-05
K261002Pectus Blu SystemBiomet Microfixation2026-06-02
K261038Xpert PFPNewclip Technics2026-05-29
K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026-05-09

Legacy Summary#

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FDA Review#

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