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FDA 510(k)

MotoBAND CP Implant System

K-Number: K193452 · 2020-01-10

ApplicantCrossroads Extemity Systems, LLC
Decision Date2020-01-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MotoBAND CP Implant System is a medical device manufactured by Crossroads Extemity Systems, LLC. It received FDA 510(k) clearance on 2020-01-10 under approval number K193452. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MotoBAND CP Implant System?

MotoBAND CP Implant System is a medical device that received FDA 510(k) clearance on 2020-01-10. It is manufactured by Crossroads Extemity Systems, LLC. The 510(k) number is K193452.

When was MotoBAND CP Implant System approved by the FDA?

MotoBAND CP Implant System received FDA 510(k) clearance on 2020-01-10, under approval number K193452.

What company makes MotoBAND CP Implant System?

MotoBAND CP Implant System is manufactured by Crossroads Extemity Systems, LLC.

What is the FDA product code for MotoBAND CP Implant System?

The FDA product code for MotoBAND CP Implant System is HRS.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025) PMID: 41966145 From Registry to Reality: Opportunities to Enhance Post-market Surveillance of High-Risk Medical Devices Comment on "Quality and Utility of European Cardiovascular and Orthopaedic Registries for the Regulatory Evaluation of Medical Device Safety and Performance Across the Implant Lifecycle: A Systematic Review". International journal of health policy and management (2025) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by Crossroads Extemity Systems, LLC

K191342CrossRoads Screw System K190722TriMAX Implant System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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