FDA.report

510(k) K201227

Device
Phantom® Hindfoot TTC/TC Nail System
Applicant
Paragon 28, Inc.
510(k) number
K201227
Product code
HSB  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-17
Date received
2020-05-06
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
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
Haylie Hertz
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

Related GUDID Devices

Primary DIBrandCompanyPublished
00889795136497Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136558Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136398Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136312Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136275Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795135360Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136305Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136381Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136343Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136329Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136541Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136466Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136428Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136404Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136459Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136534Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136510Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136473Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136374Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136282Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136268Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136350Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136527Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136435Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136411Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136503Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136336Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136299Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136480Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05
00889795136442Phantom Hindfoot TTC/TC Nail SystemPARAGON 28, INC.2024-04-05

Legacy Summary

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FDA Review

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