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FDA 510(k)

MIS Bunion System

K-Number: K181872 · 2019-02-19

ApplicantCrossroads Extremity Systems, LLC
Decision Date2019-02-19
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MIS Bunion 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 2019-02-19 under 510(k) number K181872. 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 MIS Bunion System?

MIS Bunion System is a medical device that received FDA 510(k) clearance on 2019-02-19. The listed applicant is Crossroads Extremity Systems, LLC. The 510(k) number is K181872.

When did MIS Bunion System receive FDA 510(k) clearance?

MIS Bunion System received FDA 510(k) clearance on 2019-02-19, under 510(k) number K181872.

Who is the listed applicant for MIS Bunion 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 MIS Bunion System?

The FDA product code for MIS Bunion System is HRS.

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.

K253178TRILEAP Plating SystemK241050CrossRoads Modular Tray SystemK230591TriLEAP Plating SystemK223342MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion SystemK220797FootHold SystemK202268CrossRoads Tray System

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Related Devices (Code: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

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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