FDA.reportPublic FDA data

510(k) K242452

Device
Monkey Bars Pin to Bar External Fixation System
Applicant
Paragon 28, Inc.
510(k) number
K242452
Product code
KTT
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-01
Date received
2024-08-19
Regulation
888.3030
Classification name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Edward Wells-Spicer
Address
14445 Grasslands Dr. Englewood CO US 80112 80112

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KTT#

510(k), Device, Applicant table
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K243798Orthex External Fixation SystemOrthoPediatrics Corp.2025-03-07
K241563Extremity Medical External Fixation SystemExtremity Medical, LLC2025-02-21
K242861TrueLok ElevateOrthofix Srl2024-12-03
K241769Response Ortho Metaphyseal Hinge Fixator SystemResponse Ortho Solutions, LLC2024-09-18