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510(k) Data Aggregation
K Number
K113311Device Name
TIO2MESH TM
Manufacturer
Date Cleared
2012-07-17
(251 days)
Regulation Number
878.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOCER ENTWICKLUNGS GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TiO2Mesh™ is a surgical mesh implant specifically indicated for repair of tissue defects of the abdominal wall, where a non-reabsorbable support material is required. Relevant applications include the repair of inguinal and incisional hernia in all common surgical methods. TiO2Mesh™ can be used for both laparoscopic and other open procedures.
Device Description
TiO2Mesh™ is made from a monofilament polypropylene thread and has a large-pore structure with blue orientation stripes. The surgical mesh implant has a titanium dioxide coated surface. The fabric can be stretched in both directions and is highly flexible to react to body dynamics in terms of elasticity. TiO2Mesh™ is available in different shapes and sizes (product flyer TiO2Mesh™ ).
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