ExactechGPS® System
K-Number: K233299 · 2024-01-26
ApplicantBlue Ortho
Decision Date2024-01-26
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
ExactechGPS® System is a medical device manufactured by Blue Ortho. It received FDA 510(k) clearance on 2024-01-26 under approval number K233299. 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 ExactechGPS® System?
ExactechGPS® System is a medical device that received FDA 510(k) clearance on 2024-01-26. It is manufactured by Blue Ortho. The 510(k) number is K233299.
When was ExactechGPS® System approved by the FDA?
ExactechGPS® System received FDA 510(k) clearance on 2024-01-26, under approval number K233299.
What company makes ExactechGPS® System?
ExactechGPS® System is manufactured by Blue Ortho.
What is the FDA product code for ExactechGPS® System?
The FDA product code for ExactechGPS® System 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.