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

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