FDA.report

510(k) K253591

Device
Phantom® Hindfoot TTC/TC Nail System
Applicant
Paragon 28, Inc.
510(k) number
K253591
Product code
HSB
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-05
Date received
2025-11-17
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
Brittanie Dogue
Address
14445 Grasslands Dr. Englewood CO US 80112 80112

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
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
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