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510(k) Data Aggregation
K Number
K123356Device Name
FORTIVA PORCINE DERMIS
Manufacturer
RTI BIOLOGICS, INC.
Date Cleared
2013-03-05
(125 days)
Product Code
FTM
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
RTI BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and /or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.
The device is intended for single patient use only.
Device Description
The proposed device is an implantable surgical mesh comprised of non-crosslinked porcine dermis that has been processed, terminally sterilized and is stored hydrated and ready to use. The proposed device is designed to perform as a scaffold that allows for neovascularization and permits replacement of the device with host tissue. The device in its unopened, undamaged package is sterile.
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K Number
K091142Device Name
TUTOPATCH, TUTOMESH, MODELS 68350, 68351, 68352, 68353, 68354, 68355, 68356, 68357, 68358
Manufacturer
RTI BIOLOGICS, INC.
Date Cleared
2009-08-31
(133 days)
Product Code
FTM, COD
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
RTI BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for implantation to repair, reinforce and/or supplement soft tissue. This device is indicated for use in general and plastic surgery applications. This device is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include but are not limited to: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including but not limited to diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Device Description
These are borne pericardium surgical mesh devices processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. These devices consist of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, they have multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retain the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.
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K Number
K081538Device Name
TUTOPATCH, TUTOMESH
Manufacturer
RTI BIOLOGICS, INC.
Date Cleared
2008-06-19
(17 days)
Product Code
FTM, DXZ, OXH, PAJ
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
RTI BIOLOGICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These products are indicated for use in general and plastic surgery applications. These products are intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: gastric banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
Device Description
TUTOMESH® is a bovine pericardium surgical mesh processed with the Tutoplast® solvent dehydration process followed by gamma irradiation. The TUTOMESH® device consists of collagenous connective tissue with three-dimensional intertwined fibers. Therefore, it has a multidirectional mechanical strength and can be fixed regardless of the direction of the graft. Collagenous connective tissue with multidirectional fibers retains the mechanical strength and elasticity of the native tissue, while providing the basic structure to support replacement by new endogenous tissue.
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