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 a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2019-02-19 under approval 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. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K181872.
When was MIS Bunion System approved by the FDA?
MIS Bunion System received FDA 510(k) clearance on 2019-02-19, under approval number K181872.
What company makes MIS Bunion System?
MIS Bunion System is manufactured by Crossroads Extremity Systems, LLC.
What is the FDA product code for MIS Bunion System?
The FDA product code for MIS Bunion System is 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.