MIS Bunion Plating System
K-Number: K190658 · 2019-04-12
ApplicantCrossroads Extremity Systems, LLC
Decision Date2019-04-12
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
MIS Bunion Plating System is a medical device manufactured by Crossroads Extremity Systems, LLC. It received FDA 510(k) clearance on 2019-04-12 under approval number K190658. 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 Plating System?
MIS Bunion Plating System is a medical device that received FDA 510(k) clearance on 2019-04-12. It is manufactured by Crossroads Extremity Systems, LLC. The 510(k) number is K190658.
When was MIS Bunion Plating System approved by the FDA?
MIS Bunion Plating System received FDA 510(k) clearance on 2019-04-12, under approval number K190658.
What company makes MIS Bunion Plating System?
MIS Bunion Plating System is manufactured by Crossroads Extremity Systems, LLC.
What is the FDA product code for MIS Bunion Plating System?
The FDA product code for MIS Bunion Plating 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.