FDA.report

510(k) K261043

Device
AUTOBAHN™ Nailing System
Applicant
Globus Medical, Inc.
510(k) number
K261043
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2026-03-31
Regulation
888.3020
Classification name
Rod, Fixation, Intramedullary And Accessories
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
Suganya Gopalakrishnan
Address
2560 General Armistead Ave. Audubon PA US 19403 19403

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Other 510(k) Records For Product Code HSB

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K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAOrthofix Srl2026-05-08
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
K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemStryker GmbH2025-08-20
K250163T2 Alpha Femur Retrograde Nailing SystemStryker GmbH2025-08-13