Search Results
Found 2 results
510(k) Data Aggregation
K Number
K191749Device Name
TIGR Matrix Surgical Mesh, TIGR Surgical Mesh
Manufacturer
Novus Scientific AB
Date Cleared
2020-03-26
(269 days)
Product Code
OWT, FTL, OOD
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
Novus Scientific AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TIGR Matrix Surgical Mesh is indicated for use in the reinforcement of soft tissue, where weakness exists in patients undergoing plastic and reconstructive surgery, or for use in procedures involving soft tissue repair, such as for the repar of hernias or other fascial defects that require the addition of a reinforcing material to obtain the desired surgical result.
Device Description
The TIGR™ Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers. possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers. In vitro testing showed that the fast-resorbing fiber (glycolide, lactide and trimethylene carbonate) loses its mechanical strength after 2 weeks and in vivo studies in the abdominal wall of sheep showed that the fast-resorbing fiber is fully absorbed after 4 months. The same in vitro testing showed that the slow-resorbing fiber (lactide and trimethylene carbonate) maintains its mechanical strength for 6 months and in vivo studies in the abdominal wall of sheep indicated that the slow-resorbing fiber is absorbed after approximately 36 months.
Ask a Question
K Number
K163005Device Name
TIGR Matrix Surgical Mesh
Manufacturer
NOVUS SCIENTIFIC AB
Date Cleared
2017-07-27
(272 days)
Product Code
OWT
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
NOVUS SCIENTIFIC AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TIGR® Matrix Surgical Mesh is intended for use in reinforcement of soft tissue where weakness exists.
Device Description
TIGR® Matrix Surgical Mesh is knitted from two different synthetic resorbable fibers, possessing different degradation characteristics. The fast-resorbing fiber, making up approximately 40% of the matrix by weight, is a copolymer of glycolide, lactide, and trimethylene carbonate. The slow-resorbing fiber, making up approximately 60% of the matrix by weight, is a copolymer of lactide, and trimethylene carbonate. Both fibers degrade by bulk hydrolysis once implanted, resulting in a decreasing strength retention followed by mass loss of the fibers.
Ask a Question
Page 1 of 1