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510(k) Data Aggregation
K Number
K191670Device Name
CureOs TCP
Date Cleared
2020-08-04
(410 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Linacol Muh Dan Kim Cev Tek Med Ith Ihr San Ve Tic
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
CureOsTCP is indicated only for filling bone voids or defects that are not intrinsic to the bony structure. CureOs TCP is to be gently packed into bony voids or gaps of the skeletal system (such as the extremities, and the pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. CureOs TCP is a bone graft substitute that resorbs and is replaced with bone during the healing process.
Device Description
The CureOs 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 500pmn. The device is available in a variety of shapes and sizes.
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