FDA.report

510(k) K260934

Device
TITAN Nail; APTUS K-Wire System
Applicant
Medartis AG
510(k) number
K260934
Product code
HWC
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-17
Date received
2026-03-20
Regulation
888.3040
Classification name
Screw, Fixation, Bone
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Special
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 HWC

510(k)DeviceApplicantDecision date
K261241TriMed Compression ScrewsTriMed, Inc.2026-05-14
K254215Arthrex Beaming SystemArthrex, Inc.2026-05-08
K254077OSSIOfiber® Threaded Trimmable Fixation NailOSSIO , Ltd.2026-05-01
K252699CoAptix S SystemUniversity of Utah, Department of Orthopaedics2026-04-10
K253042Tyber Medical Trauma ScrewTyber Medical, LLC2026-04-03
K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QuattroMedShape, Inc.2026-03-18
K260361Treace Medical Concepts (TMC) Screw Fixation SystemTreace Medical Concepts, Inc.2026-03-06
K252901Tyber Medical Trauma ScrewTyber Medical, LLC2025-12-31
K251555Ultra™ Compression Screw SystemPace Surgical2025-11-06
K252312Eleganz IM Threaded Nail System (IM Threaded Nail System)Dev42025-10-10
K250536MetaFore Small Screw SystemExtremity Medical, LLC2025-10-08
K252758Cannulated Screw and Kirschner (K wire) SystemOrthonovis, Inc.2025-10-02
K252019CurvaFix Low Profile SystemCurvafix, Inc.2025-08-29
K251382Phoenix Sinus Tarsi Stent SystemAstra Orthomed, Inc.2025-08-27
K250867Dunamis Screw and Suture Locking SystemDunamis Medical, LLC2025-08-15