SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)
K-Number: K190069 · 2019-05-14
ApplicantArrowhead De, LLC
Decision Date2019-05-14
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device manufactured by Arrowhead De, LLC. It received FDA 510(k) clearance on 2019-05-14 under approval number K190069. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is a medical device that received FDA 510(k) clearance on 2019-05-14. It is manufactured by Arrowhead De, LLC. The 510(k) number is K190069.
When was SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) approved by the FDA?
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) received FDA 510(k) clearance on 2019-05-14, under approval number K190069.
What company makes SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?
SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is manufactured by Arrowhead De, LLC.
What is the FDA product code for SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS)?
The FDA product code for SixFix Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is KTT.
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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.