FDA 510(k)

Flexible Suturing System with Anchors (FSSA)

Número K: K222589 · 2023-01-26

Data da decisão2023-01-26

Código do produtoMBI

Comité consultivoOR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Flexible Suturing System with Anchors (FSSA) is the device name listed in this FDA 510(k) record. The listed applicant is Integrity Orthopaedics, Inc.. It received FDA 510(k) clearance on 2023-01-26 under 510(k) number K222589. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

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. The listed applicant is Integrity Orthopaedics, Inc.. The 510(k) number is K222589.

When did Flexible Suturing System with Anchors (FSSA) receive FDA 510(k) clearance?

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

Who is the listed applicant for Flexible Suturing System with Anchors (FSSA)?

The FDA 510(k) record lists Integrity Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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