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510(k) Data Aggregation
K Number
K132470Device Name
SOLUM IV BONE VOID FILLER
Manufacturer
Date Cleared
2014-05-21
(287 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
SPINESMITH PARTNERS, LLP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Solum IV ® is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (i.e., extremities and pelvis) in conjunction with an equal volume of bone marrow aspirate. These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.
Device Description
Solum IV ® is a resorbable porous calcium phosphate bone void filler mixed with a porcine gelatin based carrier. It is an osteoconductive implant with a multidimensional porosity similar to human cancellous bone and acts as a scaffold for the in-growth of new bone.It is provided sterile in various configurations within a double sealed package containing a mixing spatula.
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