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510(k) K201147

Device
Elos® Intramedullary Nailing System
Applicant
Intrauma S.p.A.
510(k) number
K201147
Product code
HSB  
Decision
Substantially Equivalent (SESE)
Decision date
2021-07-19
Date received
2020-04-29
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

Related Records

Applicant Contact

Contact
Piero Costa
Address
Via Genova 19 Rivoli (To) IT 10098 10098

FDA Registration Numbers

Source Documents

510(k) summary PDF

Related GUDID Devices

Primary DIBrandCompanyPublished
08056693001864ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693000546ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693000508ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693000577ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001697ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001703ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001710ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001727ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001734ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001758ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001765ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001789ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001796ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001826ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001833ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001857ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001840ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693000522ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001918ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693000492ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001819ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001741ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001888ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001772ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001925ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001901ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001895ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001802ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001932ELOS INSTRUMENTSINTRAUMA SPA2023-10-20
08056693001871ELOS INSTRUMENTSINTRAUMA SPA2023-10-20

Other 510(k) Records For Product Code HSB  

510(k)DeviceApplicantDecision date
K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl2026-05-19
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl2026-05-08
K261043AUTOBAHN™ Nailing SystemGlobus Medical, Inc.2026-04-24
K252016Arthrex Humeral NailsArthrex, Inc.2026-03-20
K252961Fusion FibFix NailFusion Orthopedics USA, LLC2026-03-18
K253566Affixus Retrograde Femoral Nailing SystemZimmer, Inc.2026-03-12
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

Legacy Summary

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FDA Review

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