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MotoBAND

FDA UDI

Class II (US FDA UDI)

by Crossroads Extremity Systems Llc

Identity

Trade Name
MotoBAND FDA UDI
Generic Name
Bone-resection orthopaedic reamer, single-use 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. When used for these indications, certain plates within this system may be used with the MotoCLIP Implant System FDA UDI
Model / Reference
MotoBAND CP Instrument Kit - 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. When used for these indications, certain plates within this system may be used with the MotoCLIP Implant System FDA UDI

Identifiers

Catalog Number
1500-4500 FDA UDI
Primary DI / UDI-DI
00815432023066 FDA UDI
510(k) Number
K152306 FDA UDI
K160300 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
GMDN Term
Bone-resection orthopaedic reamer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K152306 also covers:

K160300 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Crossroads Extremity Systems Llc

Sources (1)

  • FDA UDI 15128de5-2951-4e0f-a6db-b6a6258eec12 37 fields · synced May 30, 2026