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Arthrex Meniscal Dart System

by Arthrex, Inc.

510(k) K983577

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK983577 Date13 Aug 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
MAI
Device class
Class II
Regulation
21 CFR Part 888.3030
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Arthrex Meniscal Dart System is a Class 2 Orthopedic device, specifically a Fastener, Fixation, Biodegradable, Soft Tissue device. It is used in orthopedic procedures, particularly in meniscal repair. The device is designed to address meniscus pathology.

The Arthrex Meniscal Dart System is supplied sterile, and is intended for single-use. It is available in various quantities, including a pack of 5. The device has been cleared through the Traditional 510(k) pathway and has a product code of MAI. It is manufactured by Arthrex, Inc. and has been assigned a regulation number of 888.3030.

Other devices from Arthrex, Inc.

See all devices from Arthrex, Inc. →

Questions

AI-generated answers, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Arthrex Meniscal Dart System used for?

    The Arthrex Meniscal Dart System is used in orthopedic procedures, particularly in meniscal repair, to address meniscus pathology.

  • Is the Arthrex Meniscal Dart System supplied sterile?

    Yes, the Arthrex Meniscal Dart System is supplied sterile and is intended for single-use.

  • What is the product code for the Arthrex Meniscal Dart System?

    The product code for the Arthrex Meniscal Dart System is MAI.

  • How is the Arthrex Meniscal Dart System packaged?

    The Arthrex Meniscal Dart System is available in various quantities, including a pack of 5.