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FDA 510(k)

Suture Button Repair System

K-Number: K261770 · 2026-07-29

ApplicantSkeletal Dynamics, Inc.
Decision Date2026-07-29
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Suture Button Repair System is the device name listed in this FDA 510(k) record. The listed applicant is Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2026-07-29 under 510(k) number K261770. 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 Suture Button Repair System?

Suture Button Repair System is a medical device that received FDA 510(k) clearance on 2026-07-29. The listed applicant is Skeletal Dynamics, Inc.. The 510(k) number is K261770.

When did Suture Button Repair System receive FDA 510(k) clearance?

Suture Button Repair System received FDA 510(k) clearance on 2026-07-29, under 510(k) number K261770.

Who is the listed applicant for Suture Button Repair System?

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

What is the FDA product code for Suture Button Repair System?

The FDA product code for Suture Button Repair System is MBI.

Other records listing Skeletal Dynamics, Inc. as applicant

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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.

K262369AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved DownStryker EndoscopyK261632Thunderbolt 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.K253130Dione PEEK Screw SystemZheJiang Decans Medical Devices Co., Ltd.K261363Y-Knotless™ Flex AnchorsCONMED Corporation

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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