DURAGEN II DURAL REGENERATION MATRIX— 510(k) K043427

Clearance details

Applicant

Integra Lifesciences Corp.

Product code

Code GXQ

Device class

Class 2

Regulation

21 CFR 882.5910

Advisory panel

Neurology

Date received

2004-12-13

Decision date

2005-01-12

Decision

Substantially Equivalent

Clearance type

Special

Location

Plainsboro, NJ, US

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Death

11

Injury

446

Other

1

Total

458

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-1283-2013 — Suturable DuraGen Dural Regenerative Matrix Suturable DuraGen Dural Regenerative Matrix is an absorbable implant for repair of dural defects. Suturable DuraGen is an easy to handle, soft, white, pliable, nonfriable, porous collagen matrix with a mechanically strengthened collagen component. Suturable DuraGen is supplied sterile, non-pyrogenic, for single use in double peel packages in a variety of sizes. Suturable DuraGen may be applied using either on-lay or suturing techniques depending on clinical need and surgeon preference.Class II·Terminated·Integra LifeSciences Corporation·20130328

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K043427.