AlignMATE Lapidus Arthrodesis System
K-Number: K162391 · 2017-02-21
ApplicantArthrosurface, Inc.
Decision Date2017-02-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
AlignMATE Lapidus Arthrodesis System is a medical device manufactured by Arthrosurface, Inc.. It received FDA 510(k) clearance on 2017-02-21 under approval number K162391. 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 AlignMATE Lapidus Arthrodesis System?
AlignMATE Lapidus Arthrodesis System is a medical device that received FDA 510(k) clearance on 2017-02-21. It is manufactured by Arthrosurface, Inc.. The 510(k) number is K162391.
When was AlignMATE Lapidus Arthrodesis System approved by the FDA?
AlignMATE Lapidus Arthrodesis System received FDA 510(k) clearance on 2017-02-21, under approval number K162391.
What company makes AlignMATE Lapidus Arthrodesis System?
AlignMATE Lapidus Arthrodesis System is manufactured by Arthrosurface, Inc..
What is the FDA product code for AlignMATE Lapidus Arthrodesis System?
The FDA product code for AlignMATE Lapidus Arthrodesis 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.