510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K092388Substantially Equivalent

Duragen Plus Dural Regeneration Matrix- Spinal Matrix, Model Dp2013sm, Integra Spinal Mend Dural Regeneration Matrix, Mo

Integra LifeSciences Corporation, Planisboro NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092388 is the FDA 510(k) clearance record for DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO, a class II device, cleared for Integra LifeSciences Corporation on under FDA product code GXQ (Dura Substitute). FDA records list 94 510(k) clearances for Integra LifeSciences Corporation, from to . As of , FDA records show no recalls naming K092388.

Clearance record

Decision date
Received
(169 days to decision)
Product code
GXQ Dura Substitute
Regulation
21 CFR 882.5910
Device class
Class II
Review panel
Neurology
Applicant
Integra LifeSciences Corporation 311 Enterprise Dr., Planisboro NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GXQ

Trailing 12 months

FDA records hold no clearances under product code GXQ in the trailing twelve months.

FDA records show no clearances under product code GXQ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code GXQ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260