FDA Product Code GXQ: Dura Substitute

Cleared Jan 12, 2005

DURAGEN II DURAL REGENERATION MATRIX

K043427

Integra Lifesciences Corp.

Neurology · 30d

Cleared Dec 01, 2004

DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE

K040888

Collagen Matrix, Inc.

Neurology · 240d

Cleared Jul 27, 2004

DUREPAIR DURA REGENERATION MATRIX

K041000

Medtronic Neurosurgery

Neurology · 99d

Cleared Jun 22, 2004

CODMAN DURAFORM DURAL GRAFT IMPLANT

K041518

Codman & Shurtleff, Inc.

Neurology · 15d

Cleared Sep 30, 2003

DURAGEN PLUS DURAL GRAFT MATRIX

K032693

Integra Lifesciences Corp.

Neurology · 28d

Cleared Sep 08, 2003

DURASIS DURAL SUBSTITUTE

K031850

Cook Biotech, Inc.

Neurology · 84d

Cleared Nov 08, 2002

PRECLUDE MVP DURA SUBSTITUTE

K021477

W.L. Gore & Associates, Inc.

Neurology · 184d

Cleared May 02, 2000

SHELHIGH NO-REACT DURA SHIELD

K982101

Shelhigh, Inc.

Neurology · 687d

Cleared Mar 13, 2000

CODMAN ETHISORB DURA PATCH

K991413

Johnson & Johnson Professionals, Inc.

Neurology · 325d

Cleared Jul 06, 1999

DURAGEN DURAL GRAFT MATRIX

K982180

Integra Lifesciences Corp.

Neurology · 379d

Cleared Mar 15, 1999

PRECLUDE ACUSEAL DURA SUBSTITUTE

K984534

W.L. Gore & Associates, Inc.

Neurology · 84d

Cleared Jul 30, 1998

DURA-GUARD - DURAL REPAIR PATCH

K982282

Bio-Vascular, Inc.

Neurology · 30d

Cleared May 13, 1998

DURA-PATCH MODEL DP-XXX

K980548

Bridger Biomed, Inc.

Neurology · 90d

Cleared Dec 24, 1997

DURA-GUARD-DURAL REPAIR PATCH

K973706

Bio-Vascular, Inc.

Neurology · 86d

Cleared Dec 09, 1997

LYOPLANT DURA SUBSTITUTE(VARIOUS)

K970851

Aesculap, Inc.

Neurology · 277d

Cleared May 10, 1996

NEURO-PATCH

K960470

Aesculap, Inc.

Neurology · 99d

Cleared Nov 01, 1995

PRECLUDE DURA SUBSTITUTE

K953969

W.L. Gore & Associates, Inc.

Neurology · 71d

Cleared Jun 02, 1995

DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE

K950956

Bio-Vascular, Inc.

Neurology · 92d