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Found 6 results
510(k) Data Aggregation
K Number
K172636Device Name
VitaMESH Macroporous PP Surgical Mesh
Manufacturer
Proxy Biomedical Ltd.
Date Cleared
2018-04-30
(241 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Proxy Biomedical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing
Device Description
The synthetic mesh is constructed of knitted filaments of an alternative polypropylene resin. This material change does not affect the device description (or the device description on the package and instructions for use.) The proposed VitaMESH™ with the material supplier change is knitted by the same process as the predicate VitaMESH™, which interlinks each fiber junction and which provides for elasticity in both directions are.
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K Number
K111121Device Name
VITAMESH (TM) BLUE LIGHTWEIGHT MACROPOROUS PP SURGICAL MESH
Manufacturer
PROXY BIOMEDICAL LTD.
Date Cleared
2011-05-13
(22 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PROXY BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
Device Description
VitaMesh™ Blue Lightweight Macroporous PP Surgical Mesh, a modification of VitaMesh™ Surgical Mesh, is a non-absorbable, synthetic mesh, with a blue colorant to enhance visibility. The more open weave and reduced thickness provides a more drapeable and lighter texture.
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K Number
K060520Device Name
VITAMESH MACROPOROUS PP SURGICAL MESH
Manufacturer
PROXY BIOMEDICAL LTD.
Date Cleared
2006-03-28
(29 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PROXY BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proxy Biomedical VITAMESH™ surgical mesh is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
Device Description
The VITAMESH TM is a non-absorbable, synthetic mesh, constructed of knitted filaments of Polyproylene. The VITAMESH™ is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the patient's needs. The mesh is approximately 0.010" thick, and exhibits high burst strength and tensibe strength The VITAMESH™ is knitted by a process which provides for elasticity in both digetions. Use of VITAMESH™ allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
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K Number
K052100Device Name
MODIFICATION TO MOTIFMESH SOFT TISSUE PATCH
Manufacturer
PROXY BIOMEDICAL LTD.
Date Cleared
2005-08-11
(8 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PROXY BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Proxy Biomedical MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hernia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
Device Description
Proxy Biomedical MotifMesh 100 Soft Tissue Patch is a non-absorbable, inert, sterile, porous surgical soft tissue patch produced from expanded polytetrafluoroethylene. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The Soft tissue patch measures 0.006" +/- 0.001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESHTM Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a fibrous wall.
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K Number
K051245Device Name
POLYFORM SYNTHETIC MESH
Manufacturer
PROXY BIOMEDICAL LTD.
Date Cleared
2005-06-17
(32 days)
Product Code
OTO
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PROXY BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Polyform™ Synthetic Mesh is indicated for tissue reinforcement and stabilization of fascial structures of the pelvic floor via an abdominal approach, where surgical treatment is intended, either as mechanical support or bridging material for the fascial defect.
Device Description
Polyform™ Synthetic Mesh is intended to be utilized for surgical procedures pertaining to the pelvic floor. Polyform Synthetic Mesh is supplied sterile and provided in sheet form to be cut to size and sutured by the surgeon to meet the individual patient's needs. Polyform Synthetic Mesh is manufactured from monofilament polypropylene fibers.
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K Number
K050678Device Name
MOTIFMESH SOFT TISSUE PATCH
Manufacturer
PROXY BIOMEDICAL LTD.
Date Cleared
2005-05-20
(65 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
PROXY BIOMEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MOTIFMESH™ Soft Tissue Patch is intended to assist in the repair and/or reinforcement of hemia and other fascial defects requiring the additional support of a nonabsorbable implant during and after wound healing.
Device Description
MOTIFMESH™ Soft Tissue Patch is a nonabsorbable, inert, sterile, macro porous surgical soft tissue patch Produced from polytetrafluoroethylene. The MotifMesh TM Soft Tissue Patch is designed to facilitate the reinforcement and repair of damaged or ruptured soft tissue structures. The implant has a structure characterized by closed cell openings in a high strength film. The construction allows the soft tissue patch to be stretched in both directions, to accommodate and reinforce tissue defects. The soft tissue patch measures 0.006''+/. 001" in thickness and exhibits high burst strength and tensile strength. Use of MOTIFMESH™ Soft Tissue Patch allows a fibroblastic response through the interstices of the implant, forming a strong fibrous wall.
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