FDA.reportPublic FDA data

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

Applicant Contact#

Contact
Jessica Powers
Address
2850 Frontier Dr. Warsaw IN US 46582 46582

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HRS#

510(k), Device, Applicant table
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K254288Clavicle Fixation SystemSkeletal Dynamics, Inc.2026-03-23
K260448CastleLoc Pectus Bar SystemL&K BIOMED Co., Ltd.2026-03-19
K260390Super Upper Limbs Versalock Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-03-17