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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Medacta International S.A.. It received FDA 510(k) clearance on 2025-07-01 under 510(k) 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. The listed applicant is Medacta International S.A.. The 510(k) number is K251933.

When did SnugFit ASA Extension receive FDA 510(k) clearance?

SnugFit ASA Extension received FDA 510(k) clearance on 2025-07-01, under 510(k) number K251933.

Who is the listed applicant for SnugFit ASA Extension?

The FDA 510(k) record lists Medacta International S.A. as the applicant. This does not by itself establish the device manufacturer.

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.

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