Navigated INFINITY Instruments
K-Number: K181111 · 2018-05-17
ApplicantMedtronic Sofamor Danek USA, Inc.
Decision Date2018-05-17
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Navigated INFINITY Instruments is a medical device manufactured by Medtronic Sofamor Danek USA, Inc.. It received FDA 510(k) clearance on 2018-05-17 under approval number K181111. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Navigated INFINITY Instruments?
Navigated INFINITY Instruments is a medical device that received FDA 510(k) clearance on 2018-05-17. It is manufactured by Medtronic Sofamor Danek USA, Inc.. The 510(k) number is K181111.
When was Navigated INFINITY Instruments approved by the FDA?
Navigated INFINITY Instruments received FDA 510(k) clearance on 2018-05-17, under approval number K181111.
What company makes Navigated INFINITY Instruments?
Navigated INFINITY Instruments is manufactured by Medtronic Sofamor Danek USA, Inc..
What is the FDA product code for Navigated INFINITY Instruments?
The FDA product code for Navigated INFINITY Instruments is OLO.
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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.