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510(k) Data Aggregation
K Number
K112499Device Name
BIOMERIX COMPOSITE SURGICAL MESH
Manufacturer
BIOMERIX CORPORATION
Date Cleared
2011-12-23
(115 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOMERIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomerix Composite Surgical Mesh is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery.
Device Description
Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.
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K Number
K112567Device Name
BIOMERIX ASSURE
Manufacturer
BIOMERIX CORPORATION
Date Cleared
2011-12-23
(112 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOMERIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biomerix ASSURE™ is intended for repair and/or reinforcement of soft tissues where weakness exists in plastic and reconstructive surgery. The resorbable protective film minimizes tissue attachment to the device.
Device Description
Biomerix ASSURE is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film.
The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of tissue attachment to the device during the wound healing period.
ASSURE is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.
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K Number
K093123Device Name
BIOMERIX VENTRAL HERNIA REPAIR MESH, MODEL SM3-TAB
Manufacturer
BIOMERIX CORPORATION
Date Cleared
2010-05-13
(223 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOMERIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomerix Ventral Hernia Repair Mesh is intended for the reconstruction of hernias and soft tissue deficiencies and for the temporary bridging of fascial defects. The resorbable protective film minimizes tissue attachment to the device in case of direct contact with the viscera.
Device Description
The Biomerix Ventral Hernia Repair Mesh is a sterile, composite mesh comprised of three layers: 1) a thin sheet of the Biomerix Biomaterial™, 2) a layer of knitted polypropylene monofilament fibers and 3) a resorbable lactide-caprolactone film. The resorbable film separates the permanent mesh from underlying tissues and organ surfaces, and it is designed to minimize the risk of a tissue attachment to the device during the wound healing period. The Biomerix Ventral Hernia Repair Mesh is provided sterile for single use and is available as individually packaged thin sheets in various shapes and sizes.
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K Number
K082941Device Name
BIOMERIX COMPOSITE SURGICAL MESH, MODEL SMNR-0510 AND SMNR-1215
Manufacturer
BIOMERIX CORPORATION
Date Cleared
2009-01-07
(97 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOMERIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biomerix Composite Surgical Mesh is intended to assist in the repair and/or reinforcement of hernia and other soft tissue defects requiring additional support of a nonabsorbable implant during and after wound healing.
Device Description
Biomerix Composite Surgical Mesh is a non-absorbable porous polymer scaffold (polycarbonate polyurethane urea) incorporating knitted polypropylene monofilament fibers.
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K Number
K070961Device Name
BIOMERIX SURGICAL MESH, MODEL: RCR-01
Manufacturer
BIOMERIX CORPORATION
Date Cleared
2008-02-25
(326 days)
Product Code
FTL
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOMERIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomerix Surgical Mesh is intended for the reinforcement of the soft tissues which are repaired by suture or suture anchors during rotator cuff repair surgery.
The mesh is not intended to replace normal body structure or provide full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchor systems used to attach the tissue to the bone, provide mechanical strength for tendon repair.
Device Description
The Biomerix Surgical Mesh is a non-absorbable mesh manufactured from a polycarbonate polyurethane-urea matrix and standard polyester suture. The Biomerix Surgical Mesh is provided sterile for single use.
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K Number
K043371Device Name
BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER
Manufacturer
BIOMERIX CORPORATION
Date Cleared
2005-02-03
(57 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOMERIX CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Biomerix Vascular Occlusion Device is intended for arterial and venous embolization in the peripheral vasculature.
Device Description
The Biomerix Vascular Occlusion Device is a cylindrical device made from polycarbonate-urethane. The length of the implant is 15 mm, and it is available in diameters of 4, 6, and 8 mm. The Biomerix Vascular Occlusion Device is provided sterile for single use in its uncompressed state. The device is compressed and delivered to the target location through a commercially available peripheral introducer (5-7 F). A Loader is provided to assist with introducing the implant into the delivery catheter.
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