SnugFit ASA Extension
K-Number: K251933 · 2025-07-01
ApplicantMedacta International S.A.
Decision Date2025-07-01
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
SnugFit ASA Extension is a medical device manufactured by Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-01 under approval number K251933. 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 SnugFit ASA Extension?
SnugFit ASA Extension is a medical device that received FDA 510(k) clearance on 2025-07-01. It is manufactured by Medacta International S.A.. The 510(k) number is K251933.
When was SnugFit ASA Extension approved by the FDA?
SnugFit ASA Extension received FDA 510(k) clearance on 2025-07-01, under approval number K251933.
What company makes SnugFit ASA Extension?
SnugFit ASA Extension is manufactured by Medacta International S.A..
What is the FDA product code for SnugFit ASA Extension?
The FDA product code for SnugFit ASA Extension 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.