MotoBAND

FDA UDI

Class II (US FDA UDI)

by Crossroads Extremity Systems Llc

Identity

Trade Name: MotoBAND FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. FDA UDI
Model / Reference: MotoBAND CP, Non-Locking Screw, 3.5mm x 44mm - Sterile FDA UDI
Description: The MotoBAND™ CP Implant System is a bone plating system indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. It consist of plates and screws. FDA UDI

Identifiers

Catalog Number: 1500-3544 FDA UDI
Primary DI / UDI-DI: 00815432025190 FDA UDI
510(k) Number: K152306 FDA UDI
K160300 FDA UDI
K173710 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 3.5 Millimeter FDA UDI
Length — 44 Millimeter FDA UDI

Category: Orthopaedic bone screw (non-sliding)

MotoBAND by Crossroads Extremity Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II
ARIX System Bone Screw — Jeil Medical Corporation · Class II

Cleared under the same submission

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 II	Pending data

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Manufacturer

Manufacturer: Crossroads Extremity Systems Llc

Sources (1)

FDA UDI 8555c20d-dfd6-4d4f-8aac-8f8f4d4e8e72 37 fields · synced May 30, 2026