OLYMPIC Navigated Instruments
K-Number: K172166 · 2018-04-27
ApplicantAstura Medical
Decision Date2018-04-27
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
OLYMPIC Navigated Instruments is a medical device manufactured by Astura Medical. It received FDA 510(k) clearance on 2018-04-27 under approval number K172166. 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 OLYMPIC Navigated Instruments?
OLYMPIC Navigated Instruments is a medical device that received FDA 510(k) clearance on 2018-04-27. It is manufactured by Astura Medical. The 510(k) number is K172166.
When was OLYMPIC Navigated Instruments approved by the FDA?
OLYMPIC Navigated Instruments received FDA 510(k) clearance on 2018-04-27, under approval number K172166.
What company makes OLYMPIC Navigated Instruments?
OLYMPIC Navigated Instruments is manufactured by Astura Medical.
What is the FDA product code for OLYMPIC Navigated Instruments?
The FDA product code for OLYMPIC Navigated 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.