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FDA 510(k)

SutureLoc™ Implant

K-Number: K223284 · 2023-02-02

ApplicantArthrex, Inc.
Decision Date2023-02-02
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SutureLoc™ Implant is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2023-02-02 under approval number K223284. 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 SutureLoc™ Implant?

SutureLoc™ Implant is a medical device that received FDA 510(k) clearance on 2023-02-02. It is manufactured by Arthrex, Inc.. The 510(k) number is K223284.

When was SutureLoc™ Implant approved by the FDA?

SutureLoc™ Implant received FDA 510(k) clearance on 2023-02-02, under approval number K223284.

What company makes SutureLoc™ Implant?

SutureLoc™ Implant is manufactured by Arthrex, Inc..

What is the FDA product code for SutureLoc™ Implant?

The FDA product code for SutureLoc™ Implant is MBI.

Other Devices by Arthrex, Inc.

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Related Devices (Code: MBI)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.