Identity
- Trade Name
- MotoBAND CP FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, 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. FDA UDI
- Model / Reference
- 1500-48TP 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
- 1500-48TP FDA UDI
- Primary DI / UDI-DI
- 00850038154233 FDA UDI
- 510(k) Number
- K223342 FDA UDI
- FDA Product Code
- HRS FDA UDIHWC FDA UDIJDR FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI888.3040 FDA UDI
- Commercial Distribution
- 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
MotoBAND CP by Crossroads Extremity Systems Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K223342 also covers:
- CrossRoads™ 3.5mm x 46mm Anti-Drift Bolt — CROSSROADS EXTREMITY SYSTEMS LLC
- DynaFORCE Staple Instruments — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
- MotoBAND — CROSSROADS EXTREMITY SYSTEMS LLC
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 827c32b1-1a7f-4311-a062-d0b6a0679eeb 35 fields · synced May 31, 2026