Brainlab Compatible K2M Navigation Instruments
K-Number: K181890 · 2018-11-09
ApplicantK2m
Decision Date2018-11-09
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Brainlab Compatible K2M Navigation Instruments is a medical device manufactured by K2m. It received FDA 510(k) clearance on 2018-11-09 under approval number K181890. 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 Brainlab Compatible K2M Navigation Instruments?
Brainlab Compatible K2M Navigation Instruments is a medical device that received FDA 510(k) clearance on 2018-11-09. It is manufactured by K2m. The 510(k) number is K181890.
When was Brainlab Compatible K2M Navigation Instruments approved by the FDA?
Brainlab Compatible K2M Navigation Instruments received FDA 510(k) clearance on 2018-11-09, under approval number K181890.
What company makes Brainlab Compatible K2M Navigation Instruments?
Brainlab Compatible K2M Navigation Instruments is manufactured by K2m.
What is the FDA product code for Brainlab Compatible K2M Navigation Instruments?
The FDA product code for Brainlab Compatible K2M Navigation 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.