FDA 510(k)

Arthrex SwiveLock

K-Number: K173845 · 2018-08-06

Decision Date2018-08-06

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Arthrex SwiveLock is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2018-08-06 under approval number K173845. 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 Arthrex SwiveLock?

Arthrex SwiveLock is a medical device that received FDA 510(k) clearance on 2018-08-06. It is manufactured by Arthrex, Inc.. The 510(k) number is K173845.

When was Arthrex SwiveLock approved by the FDA?

Arthrex SwiveLock received FDA 510(k) clearance on 2018-08-06, under approval number K173845.

What company makes Arthrex SwiveLock?

Arthrex SwiveLock is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex SwiveLock?

The FDA product code for Arthrex SwiveLock 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.