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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 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.

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. 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.

Related Devices (Code: MBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262047Grappler Suture Anchor SystemParagon 28, Inc.K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261770Suture Button Repair SystemSkeletal Dynamics, Inc.K261632Thunderbolt SystemResponsive Arthroscopy, Inc.K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)Smith & Nephew, Inc.K260018Arthrex FiberButtonArthrex, Inc.

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.

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