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510(k) K203399

Device
FITBONE(R) TAA
Applicant
WITTENSTEIN Intens GmbH
510(k) number
K203399
Product code
HSB  
Decision
Substantially Equivalent (SESE)
Decision date
2021-02-17
Date received
2020-11-19
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
Hartmut Kampa
Address
Walter-Wittensstein-Strabe 1 Igersheim DE 97999 97999

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HSB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K261481Pangea Femur Reconstruction SystemStryker GmbH2026-06-29
K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.2026-06-18
K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized Orthopedics2026-06-18
K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.2026-06-17
K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.2026-06-16
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
K252196Arthrex FibuLock Nail SystemArthrex, Inc.2026-03-05
K253591Phantom® Hindfoot TTC/TC Nail SystemParagon 28, Inc.2026-03-05
K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.2026-03-04

Legacy Summary#

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FDA Review#

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