FDA.report

510(k) K260323

Device
OrthoPediatrics® Locking Cannulated Blade Plate System
Applicant
OrthoPediatrics Corp.
510(k) number
K260323
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-30
Date received
2026-01-30
Regulation
888.3030
Classification name
Plate, Fixation, Bone
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
Jessica Powers
Address
2850 Frontier Dr. Warsaw IN US 46582 46582

FDA Registration Numbers

Source Documents

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

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