Mitek TIGHT-N Anchor
K-Number: K221364 · 2022-07-11
ApplicantMedos International SARL
Decision Date2022-07-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
Mitek TIGHT-N Anchor is a medical device manufactured by Medos International SARL. It received FDA 510(k) clearance on 2022-07-11 under approval number K221364. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Mitek TIGHT-N Anchor?
Mitek TIGHT-N Anchor is a medical device that received FDA 510(k) clearance on 2022-07-11. It is manufactured by Medos International SARL. The 510(k) number is K221364.
When was Mitek TIGHT-N Anchor approved by the FDA?
Mitek TIGHT-N Anchor received FDA 510(k) clearance on 2022-07-11, under approval number K221364.
What company makes Mitek TIGHT-N Anchor?
Mitek TIGHT-N Anchor is manufactured by Medos International SARL.
What is the FDA product code for Mitek TIGHT-N Anchor?
The FDA product code for Mitek TIGHT-N Anchor is MBI.
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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.