FDA.reportPublic FDA data

510(k) K230071

Device
Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System
Applicant
Tdm Co., Ltd.
510(k) number
K230071
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-22
Date received
2023-01-10
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jung Wook Choi
Address
69, Cheomdan Venture So-Ro 37 Beon-Gil Buk-Gu KR 61003 61003

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K252961Fusion FibFix NailFusion Orthopedics USA, LLC2026-03-18
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K253517Reselute Tibial NailReselute, Inc.2026-03-10
K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2026-03-05
K252196Arthrex FibuLock Nail SystemArthrex, Inc.2026-03-05
K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.2026-03-04
K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemStryker GmbH2026-02-03
K253749Affixus® Natural Nail® Proximal Humeral SystemZimmer Switzerland Manufacturing GmbH2025-12-12
K252826ARIX Femur Nail SystemJeil Medical Corporation2025-12-10
K250197Estremo Fibular NailCitieffe S.R.L.2025-10-17
K250628DynaNail TTC Fusion SystemMedShape, Inc.2025-09-12