FiteBac CC OrthoSeal
K-Number: K210115 · 2021-07-29
ApplicantLargent Health, LLC
Decision Date2021-07-29
Product CodeDYH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
FiteBac CC OrthoSeal is a medical device manufactured by Largent Health, LLC. It received FDA 510(k) clearance on 2021-07-29 under approval number K210115. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FiteBac CC OrthoSeal?
FiteBac CC OrthoSeal is a medical device that received FDA 510(k) clearance on 2021-07-29. It is manufactured by Largent Health, LLC. The 510(k) number is K210115.
When was FiteBac CC OrthoSeal approved by the FDA?
FiteBac CC OrthoSeal received FDA 510(k) clearance on 2021-07-29, under approval number K210115.
What company makes FiteBac CC OrthoSeal?
FiteBac CC OrthoSeal is manufactured by Largent Health, LLC.
What is the FDA product code for FiteBac CC OrthoSeal?
The FDA product code for FiteBac CC OrthoSeal is DYH.
Other Devices by Largent Health, LLC
Related Devices (Code: DYH)
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.