FDA 510(k)

MotoBAND CP Implant System

K-Number: K173710 · 2018-02-12

ApplicantCrossroads Extremity Systems, LLC

Decision Date2018-02-12

Product CodeHWC

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MotoBAND CP Implant System is a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2018-02-12 under approval number K173710. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. 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 2018-02-12. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K173710.

When was MotoBAND CP Implant System approved by the FDA?

MotoBAND CP Implant System received FDA 510(k) clearance on 2018-02-12, under approval number K173710.

What company makes MotoBAND CP Implant System?

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

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

The FDA product code for MotoBAND CP Implant System is HWC. This falls under the Cardiovascular category.

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Related PubMed Literature

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)

Other Devices by Crossroads Extremity Systems, LLC

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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.