FDA.report

510(k) K253517

Device
Reselute Tibial Nail
Applicant
Reselute, Inc.
510(k) number
K253517
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-10
Date received
2025-11-12
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Brianna Prindle
Address
701 W Main St. Suite 410 Durham NC US 27701 27701

FDA Registration Numbers

Source Documents

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

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K252196Arthrex FibuLock Nail SystemArthrex, Inc.2026-03-05
K252025Active Intramedullary (AIM) Tibial Nail SystemSatori Orthopaedics, Inc.2026-03-04
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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