ClearanceBrief
510(k) K072207 ยท GXQ Dura Substitute

DURAGEN XS DURAL REGENERATION MATRIX

ApplicantIntegra Lifesciences Corp., Plainsboro NJ, US
DecisionSubstantially Equivalent, Aug 23, 2007
ReceivedAug 8, 2007
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K072207

DateFirm and productCodeLinked 510(k)
May 10, 2013Integra LifeSciences Corporation
DuraGen XS Dural Regeneration Matrix DuraGen XS Dural Regenerative Matrix is an absorbable implant for repair of dural defects. DuraGen XS is an easy to handle, soft, white, pliable, non-friable, por
Terminated		 GXQNone listed
May 10, 2013Integra LifeSciences Corporation
NeuraWrap Nerve Protector NeuraWrap Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
Terminated		 JXINone listed
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 2 inches x 2 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated		 GXQNone listed
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 3 inches x 3 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated		 GXQNone listed
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 4 inches x 5 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated		 GXQNone listed
Nov 24, 2010Integra LifeSciences Corp.
DuraGen XS Dural Regeneration Matrix: 5 inches x 7 inches. Non Pyrogenic; Rx only;Integra LifeSciences Corporation, Plainsboro, NJ 08536 USA DuraGen XS is indicated as a dural substitute for repair of
Terminated		 GXQNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.