Search Results
Found 1 results
510(k) Data Aggregation
K Number
K140913Device Name
NUROS BONE GRAFT SUBSTITUTE
Manufacturer
Date Cleared
2015-02-17
(313 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ORIENTAL RESOURCES DEVELOPMENT LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
NuROs Bone Graft Substitute is an implant intended to fill bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NuROs Bone Graft Substitute resorbs and is replaced with bone during the healing process.
Device Description
NuROs Bone Graft Substitute is an osteoconductive bone void filler with interconnective pore system. It is made of synthetic beta-tricalcium phosphate (B-TCP) indicated for bone void filling. It is suitable for individuals with bone voids of gaps, caused by surgery or trauma.
NuROs Bone Graft Substitute is available in granule type and block type with different volumes which are 1c.c, 2.5c.c, 5c.c, 10c.c, 20c.c, 25c.c and 30c.c. Granule types are provided in 0.2 ~ 0.5mm, 0.5 ~ 1mm, 1 ~ 2mm and 3mm of particle size. Block type is provided in 5mm x 5mm x 10mm, 5mm x 20mm, 10mm x 10mm x 10mm and 10mm x 25mm x 25mm size.
NuROs Bone Graft Substitute is pure ß-TCP with all crystalline phase. The Ca/P ratio is 1.5. The structure of the material is multidirectional interconnective porosity with >70% porosity. The propose device does not impart mechanical strength to surgical site.
The NuROs Bone Graft Substitute is gamma irradiated and provided for single use only.
Ask a Question
Ask a specific question about this device
Page 1 of 1