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Medeor Matrix

by Kensey Nash Corp.

510(k) K103787

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 NumberK103787 Date7 Feb 2011ClearedStatusActive

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  • Withdrawn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
FTM
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Medeor Matrix is a surgical mesh device designed for use in hernia repair and soft tissue reinforcement. Classified as a Mesh, Surgical under FDA product code FTM, it is intended for implantation in the body to provide structural support where tissue integrity is compromised, such as in inguinal, ventral, or incisional hernia repairs.

This device is supplied sterile and is intended for single-use. It is classified as a Class II medical device under FDA regulations (21 CFR 878.3300) and has received FDA 510(k) clearance through the Traditional pathway. The Medeor Matrix is intended for use in general and plastic surgery procedures and is not MRI-safe without specific manufacturer confirmation. Available in various sizes and configurations, it must be stored under controlled conditions to maintain sterility and integrity.

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Questions

AI-generated answers, 19 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 Medeor Matrix used for in surgical procedures?

    The Medeor Matrix is a surgical mesh device designed for hernia repair and soft tissue reinforcement, providing structural support where tissue integrity is compromised in inguinal, ventral, or incisional hernia repairs.

  • Is the Medeor Matrix supplied sterile and can it be reused?

    The Medeor Matrix is supplied sterile and is intended for single-use only, meaning it should not be reused on multiple patients or procedures.

  • What sizes and configurations are available for the Medeor Matrix?

    The Medeor Matrix is available in various sizes and configurations to accommodate different surgical needs, though specific dimensions are not detailed in the provided information.

  • How should the Medeor Matrix be stored to maintain its integrity?

    The Medeor Matrix must be stored under controlled conditions to maintain sterility and integrity, though specific storage requirements are not detailed in the provided information.

  • What is the regulatory classification of the Medeor Matrix?

    The Medeor Matrix is classified as a Class II medical device under FDA regulations (21 CFR 878.3300) and has received FDA 510(k) clearance through the Traditional pathway.