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FDA 510(k)

Flexible Suturing System with Anchors (FSSA)

K-Number: K222589 · 2023-01-26

ApplicantIntegrity Orthopaedics, Inc.
Decision Date2023-01-26
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Flexible Suturing System with Anchors (FSSA) is a medical device manufactured by Integrity Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-01-26 under approval number K222589. 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 Flexible Suturing System with Anchors (FSSA)?

Flexible Suturing System with Anchors (FSSA) is a medical device that received FDA 510(k) clearance on 2023-01-26. It is manufactured by Integrity Orthopaedics, Inc.. The 510(k) number is K222589.

When was Flexible Suturing System with Anchors (FSSA) approved by the FDA?

Flexible Suturing System with Anchors (FSSA) received FDA 510(k) clearance on 2023-01-26, under approval number K222589.

What company makes Flexible Suturing System with Anchors (FSSA)?

Flexible Suturing System with Anchors (FSSA) is manufactured by Integrity Orthopaedics, Inc..

What is the FDA product code for Flexible Suturing System with Anchors (FSSA)?

The FDA product code for Flexible Suturing System with Anchors (FSSA) 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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