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510(k) Data Aggregation
K Number
K111018Device Name
POLYFUSE - NEUROBONE
Manufacturer
Date Cleared
2012-02-14
(308 days)
Product Code
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
ATPAC MEDICAL LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
OsteoLaso Granule & Strips are intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoLaso Granule & Strips are indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. OsteoLaso Granule & Strips are intended to be pasked into boney voids or gaps of the skeletal system as a bone void filler (i.e., extremeties, posterolateral spine and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process.
Device Description
OsteoLaso Granule & Strips consists of beta-tricalcium phosphate, and polyphosphate. It is the bone graft substitute that regenerates bone after implantation.
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