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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 the device name listed in this FDA 510(k) record. The listed applicant is Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2018-02-12 under 510(k) 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. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K173710.

When did MotoBAND CP Implant System receive FDA 510(k) clearance?

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

Who is the listed applicant for MotoBAND CP Implant System?

The FDA 510(k) record lists Crossroads Extremity Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Crossroads Extremity Systems, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: HWC)

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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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