FDA.reportPublic FDA data

510(k) K252600

Device
Pediatric Plating Platform I Small-Mini
Applicant
OrthoPediatrics Corp.
510(k) number
K252600
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2025-10-09
Date received
2025-08-18
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
Yan Li
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
510(k)DeviceApplicantDecision date
K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.2026-07-16
K261191Alians Elbow SNewclip Technics2026-07-08
K261054RibPlate SystemStryker Leibinger GmbH & Co KG2026-07-01
K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG2026-06-26
K260958I.T.S. Clavicle Plates with Angular Stability; I.T.S. Volar Radius Plate with Angular Stability; I.T.S. Humeral Head Plate with Angular Stability; I.T.S. FR.O.H. Calcaneus Repair System; I.T.S. Pilonplate with Angular Stability; I.T.S. Olecranonplate with Angular Stability; I.T.S. Straight Plate with Angular Stability; I.T.S. Screw System; I.T.S. PRS Sacral Rod System; I.T.S. Fibula Plate PROlock with Angular Stability; I.T.S. Distal Humeral Plates with Angular Stability; I.T.S. LRS (LI.T.S. GmbH2026-06-16
K261207Exalta Proximal Tibia Plating SystemTyber Medical, LLC2026-06-12
K260761APTUS Clavicle System 2.8Medartis AG2026-06-05
K261002Pectus Blu SystemBiomet Microfixation2026-06-02
K261038Xpert PFPNewclip Technics2026-05-29
K261145Avanti Distal Elbow ORIF SystemAvanti Orthopaedics, LLC2026-05-09
K260323OrthoPediatrics® Locking Cannulated Blade Plate SystemOrthoPediatrics Corp.2026-04-30
K260054I.T.S. PRS Phoenix III.T.S. GmbH2026-04-24
K260228POYA 3.5mm Medial Proximal Tibia SystemBonebridge AG2026-04-24
K260411PC Fix SystemChest Wall Innovations, Inc.2026-04-24
K260090SMART Osteotomy SystemActis Medical Pty., Ltd.2026-04-10