EXACTECH GPS
K-Number: K152764 · 2016-07-13
ApplicantBlue Ortho
Decision Date2016-07-13
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
EXACTECH GPS is a medical device manufactured by Blue Ortho. It received FDA 510(k) clearance on 2016-07-13 under approval number K152764. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EXACTECH GPS?
EXACTECH GPS is a medical device that received FDA 510(k) clearance on 2016-07-13. It is manufactured by Blue Ortho. The 510(k) number is K152764.
When was EXACTECH GPS approved by the FDA?
EXACTECH GPS received FDA 510(k) clearance on 2016-07-13, under approval number K152764.
What company makes EXACTECH GPS?
EXACTECH GPS is manufactured by Blue Ortho.
What is the FDA product code for EXACTECH GPS?
The FDA product code for EXACTECH GPS is HAW.
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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.