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FDA 510(k)

Suture Button Repair System

K-Number: K240835 · 2024-07-19

ApplicantSkeletal Dynamics, Inc.
Decision Date2024-07-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Suture Button Repair System is a medical device manufactured by Skeletal Dynamics, Inc.. It received FDA 510(k) clearance on 2024-07-19 under approval number K240835. 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 2024-07-19. It is manufactured by Skeletal Dynamics, Inc.. The 510(k) number is K240835.

When was Suture Button Repair System approved by the FDA?

Suture Button Repair System received FDA 510(k) clearance on 2024-07-19, under approval number K240835.

What company makes Suture Button Repair System?

Suture Button Repair System is manufactured by Skeletal Dynamics, Inc..

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

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

Related Clinical Trials

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Other Devices by Skeletal Dynamics, Inc.

K201962Skeletal Dynamics Ulnar Shortening Plating System K201662REDUCT® Headless Compression Screw System K200538Skeletal Dynamics Forearm Plating System K200701Skeletal Dynamics Midshaft Humerus Plating System K200367Distal Humerus Plating System K211439Small Bone Nailing System

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Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX™ Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

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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