TriLeap Lower Extremity Anatomic Plating System

FDA UDI

Class I (US FDA UDI)

by Crossroads Extremity Systems Llc

Identity

Trade Name: TriLeap Lower Extremity Anatomic Plating System FDA UDI
Generic Name: Surgical drill guide, reusable FDA UDI
Device Name: Cone Drill Guide for 2.0 Drill Bit, Rose Red FDA UDI
Model / Reference: Cone Drill Guide for 2.0 Drill Bit, Rose Red FDA UDI
Description: Cone Drill Guide for 2.0 Drill Bit, Rose Red FDA UDI

Identifiers

Catalog Number: 03.900.312 FDA UDI
Primary DI / UDI-DI: 00810112592535 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Surgical drill guide, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical drill guide, reusable

TriLeap Lower Extremity Anatomic Plating System by Crossroads Extremity Systems Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide, reusable.

ORTHOFIX — Orthofix, Inc. · Class I
Titan™ — Ascension Orthopedics, Inc. · Class I
Medtronic Resuable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Distal Elbow Plating System — SKELETAL DYNAMICS L.L.C. · Class II
Truliant — Exactech, Inc. · Class II
Vantage — Exactech, Inc. · Class II
Legion — Smith & Nephew, Inc. · Class II
Hintermann Series — Dt Medtech, LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Crossroads Extremity Systems Llc

Sources (1)

FDA UDI 69390090-5de9-4c9f-8423-68cc87ce0caa 34 fields · synced May 30, 2026