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510(k) Data Aggregation
K Number
K120602Device Name
APACERAM BONE GRAFT SUBSTITUTE
Manufacturer
Date Cleared
2012-03-23
(24 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
HOYA CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Apaceram™ Bone Graft Substitute is a synthetic hydroxyapatite provided in several particulate and shaped sizes. It is intended for use as a bone void filler for bony voids, gaps, or defects that are not intrinsic to the stability of the bony structure. Apaceram™ is intended to be placed into bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine, or pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. It also can be used with autograft as a bone graft extender. Apaceram™ is resorbed and replaced with bone during the healing process.
Device Description
Apaceram™ is a hydroxyapatite osteoconductive bone void filler. It is available in four types: AX, B, G, and R, which vary in porosity, shape and sizes. Apaceram™ is provided sterile for single patient use. Apaceram™ is composed of calcium salts, is osteoconductive, and provides an interconnected, highly porous scaffold environment for new bone ingrowth.
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