FDA.report

510(k) K250641

Device
APEX 3D Total Ankle Replacement System
Applicant
Paragon 28, Inc.
510(k) number
K250641
Product code
HSN
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-01
Date received
2025-03-04
Regulation
888.3110
Classification name
Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
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
Edward Wells-Spicer
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

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K230313QUANTUM Patient Specific Instrumentation (PSI) SystemIn2bones Sas2023-04-06
K222835Prophecy Preoperative Navigation Alignment SystemWrightmedicaltechnologyinc2023-01-27