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510(k) Data Aggregation
K Number
K141429Device Name
SORRENTO BONE GRAFT SUBSTITUTE
Manufacturer
HAIDER BIOLOGICS, LLC
Date Cleared
2015-02-23
(269 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
HAIDER BIOLOGICS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Sorrento Bone Graft Substitute is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities and pelvis not intrinsic to the stability of the bony structure. Sorrento Bone Graft Substitute is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Sorrento Bone Graft Substitute must be wetted with bone marrow aspirate. Following placement in the bony you'd or gap (defect), Sorrento Bone Graft Substitute is resorbed and replaced with bone during the healing process.
Device Description
Sorrento Bone Graft Substitute is a resorbable bone void filler made from a matrix of highly purified collagen (ASTM F2212) that has high porosity beta tricalcium phosphate (TCP) granules (ASTM F1088) dispersed throughout. The implant is provided as sterile, non-pyrogenic, and for single use in double peel packages.
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