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Durepair Dura Regeneration Matrix

by Medtronic Neurosurgery 3 variants

510(k) K161370

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK161370 Date2 Nov 2016ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2207-2023 FDA Class II initiated 13 Jun 2023

    Dura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may present clinically with signs and symptoms of an acute inflammatory process, comparable to infection.

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  • Withdrawn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
GXQ
Device Class
Class II
Regulation
21 CFR Part 882.5910
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 5 Oct 2026

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

The Durepair Dura Regeneration Matrix is a Class II medical device classified as a dura substitute. It is intended for use in the repair of the dura mater.

This device was authorized by the FDA under a 510(k) clearance. It is manufactured by Medtronic Neurosurgery.

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