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Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model DP2013SM, Integra Spinal Mend Dural Regeneration Matrix, Mo

by Integra Lifesciences Corporation

510(k) K092388

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 NumberK092388 Date21 Jan 2010ClearedStatusActive

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  • Withdrawn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

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