FDA 510(k)

MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System

K-Number: K223342 · 2023-03-30

ApplicantCrossroads Extremity Systems, LLC

Decision Date2023-03-30

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System is a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2023-03-30 under approval number K223342. 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: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System?

MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System is a medical device that received FDA 510(k) clearance on 2023-03-30. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K223342.

When was MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System approved by the FDA?

MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System received FDA 510(k) clearance on 2023-03-30, under approval number K223342.

What company makes MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System?

MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System is manufactured by Crossroads Extremity Systems, LLC.

What is the FDA product code for MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System?

The FDA product code for MotoBAND CP Implant System: DynaBunion 4D Minimal-incision Bunion System, DynaMET Lesser TMT Fusion System is HRS.

Related Clinical Trials

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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) PMID: 33778409 Assessing the use of finite element analysis for mechanical performance evaluation of intervertebral body fusion devices. JOR spine (2021)

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.