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510(k) Data Aggregation
K Number
K050025Device Name
NANOSS BONE VOID FILLER
Manufacturer
ANGSTROM MEDICA, INC.
Date Cleared
2005-02-03
(28 days)
Product Code
MQV, FIL
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ANGSTROM MEDICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NanOss Bone Void Filler is intended only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The product is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous 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
NanOss Bone Void Filler is an osteoconductive, resorbable, calcium phosphate implant for use as a bone graft substitute or bone void filler. The device consists of prefabricated cylindrical calcium phosphate pellets. The device is radiopaque and is presterilized for single use. The nanocrystalline processing of the material results in sintered hydroxyapatite pellets that are translucent and uniform in density and strength.
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