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FDA 510(k)

MotoBand(TM) CP Implant System

K-Number: K160300 · 2016-04-22

ApplicantCrossroads Extremity Systems, LLC
Decision Date2016-04-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MotoBand(TM) CP Implant System is a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2016-04-22 under approval number K160300. 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(TM) CP Implant System?

MotoBand(TM) CP Implant System is a medical device that received FDA 510(k) clearance on 2016-04-22. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K160300.

When was MotoBand(TM) CP Implant System approved by the FDA?

MotoBand(TM) CP Implant System received FDA 510(k) clearance on 2016-04-22, under approval number K160300.

What company makes MotoBand(TM) CP Implant System?

MotoBand(TM) CP Implant System is manufactured by Crossroads Extremity Systems, LLC.

What is the FDA product code for MotoBand(TM) CP Implant System?

The FDA product code for MotoBand(TM) CP Implant System is HRS.

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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 Extremity Systems, LLC

K160118STROPP (Single Tunnel Repair of Plantar Plate) K181866MotoCLIP/HiMAX Step Staple Implant System K181410MotoCLIP/HiMAX Implant System K173710MotoBAND CP Implant System K190658MIS Bunion Plating System K181872MIS Bunion System

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Related Devices (Code: HRS)

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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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