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510(k) Data Aggregation
K Number
K073214Device Name
DUOWEDGE SYNTHETIC BONE SUBSTITUTE
Manufacturer
Date Cleared
2009-12-01
(748 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
KASIOS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
When used with appropriate opening osteotomy system devices, plates and screws, Duowedge is intended to be used as a bone void filler in tibial osteotomies. Duowedge is to be used in combination with adequate post-operative immobilization.
Device Description
The calcium phosphate ceramic Duowedge manufactured by KASIOS is designed to be used as a bone void filler tibial osteotomies. Duowedge is a synthetic bone substitute. It is a macroporous bioceramic, made of hydroxyapatite and beta tricalcium prosphate. When . it is nony site, Duowedge gradually and partially resorbs and is replaced with bone during the healing process. In addition, Duowedge is intended to be used with appropriate opening osteotomy system devices, plates and screws. Duowedge is for use in combination with adequated postoperative immobilization.
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K Number
K042340Device Name
KASIOS TCP
Manufacturer
Date Cleared
2004-11-24
(86 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
KASIOS BIOMATERIALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Kasios TCP is indicated only for filling bone voids or defects that are not intrinsic to the stability of the bony structure. Kasios TCP is to be gently packed into bony voids or gaps of the skeletal system (such as the extremities, spine and the pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Kasios TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.
Device Description
The KASIOS TCP is a synthetic resorbable calcium phosphate bone void filler. It is an osteoconductive material which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range of 200 to 500um. The device is available in a variety of shapes and sizes.
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