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510(k) Data Aggregation
K Number
K051093Device Name
OSTEOPORE PCL SCAFFOLD
Manufacturer
OSTEOPORE, INC.
Date Cleared
2006-03-17
(323 days)
Product Code
GXP
Regulation Number
882.5300Why did this record match?
Applicant Name (Manufacturer) :
OSTEOPORE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Osteopore PCL Scaffold™ Bone Filler is intended for the use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects. It is also for use in the augmentation or restoration of bony contour in the craniofacial skeleton. It should be gently packed into bony voids or gaps of the skeletal system.
Device Description
The Osteopore PCL Scaffold™ is a bone void filler. The Shape of the Osteopore PCL Scaffold™ conforms to the defect, thus maximizing direct contact with viable host bone.
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