K2M Navigation Instruments
K-Number: K201006 · 2020-08-07
ApplicantK2m, Inc.
Decision Date2020-08-07
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
K2M Navigation Instruments is a medical device manufactured by K2m, Inc.. It received FDA 510(k) clearance on 2020-08-07 under approval number K201006. 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 K2M Navigation Instruments?
K2M Navigation Instruments is a medical device that received FDA 510(k) clearance on 2020-08-07. It is manufactured by K2m, Inc.. The 510(k) number is K201006.
When was K2M Navigation Instruments approved by the FDA?
K2M Navigation Instruments received FDA 510(k) clearance on 2020-08-07, under approval number K201006.
What company makes K2M Navigation Instruments?
K2M Navigation Instruments is manufactured by K2m, Inc..
What is the FDA product code for K2M Navigation Instruments?
The FDA product code for K2M Navigation Instruments is OLO.
Related Clinical Trials
Other Devices by K2m, Inc.
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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.