Axis Plating System
K-Number: K192592 · 2019-11-21
ApplicantExtremity Medical, LLC
Decision Date2019-11-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Axis Plating System is a medical device manufactured by Extremity Medical, LLC. It received FDA 510(k) clearance on 2019-11-21 under approval number K192592. 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 Axis Plating System?
Axis Plating System is a medical device that received FDA 510(k) clearance on 2019-11-21. It is manufactured by Extremity Medical, LLC. The 510(k) number is K192592.
When was Axis Plating System approved by the FDA?
Axis Plating System received FDA 510(k) clearance on 2019-11-21, under approval number K192592.
What company makes Axis Plating System?
Axis Plating System is manufactured by Extremity Medical, LLC.
What is the FDA product code for Axis Plating System?
The FDA product code for Axis 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.