FDA.reportPublic FDA data

510(k) K253178

Device
TRILEAP Plating System
Applicant
Crossroads Extremity Systems
510(k) number
K253178
Product code
HRS
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-06
Date received
2025-09-26
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
No

Applicant Contact#

Contact
Jacqueline Gorberg
Address
6423 Shelby View Dr. Suite 101 Memphis TN US 38134 38134

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
K263269Park's Pectus SystemTdm Co., Ltd.2026-10-15
K261611TDM Large Bone Plate and Screw SystemTdm Co., Ltd.2026-10-02
K262649Alians ForearmNewclip Technics2026-09-28
K261892ProRib Fixation SystemCosta Surgical, Inc.2026-09-23
K262098EnHAnce PEEK Bunion SystemNvision Biomedical Technologies2026-09-18
K262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.2026-09-15
K261647Tempo Plating System; Ultra Compression Screw SystemPace Surgical2026-09-03
K261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim Sirketi2026-08-28
K262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-08-19
K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.2026-08-13
K261511Xpert AnkleNewclip Technics2026-07-28
K261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.2026-07-21
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