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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
Stress-therapy vibroacoustic headband 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 12mm 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
130102 FDA UDI
Primary DI / UDI-DI
00815432022625 FDA UDI
510(k) Number
K152306 FDA UDI
FDA Product Code
HRS FDA UDI
HWC FDA UDI
GMDN Term
Stress-therapy vibroacoustic headband 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

No

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

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 12 Millimeter FDA UDI
Outer Diameter — 3.5 Millimeter FDA UDI

Category: Stress-therapy vibroacoustic headband

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:

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 6ab91cb8-6422-45ab-83d6-5eabc52d1967 37 fields · synced Jun 7, 2026