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510(k) Data Aggregation
K Number
K180121Device Name
Rafugen DBM
Manufacturer
Date Cleared
2018-04-11
(85 days)
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
Cellumed Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Rafugen™ DBM is intended for use as a bone void filler in bony voids or gaps of the skeletal system (i.e., pelvis and extremities) not intrinsic to the stability of the bony structure. The voids or gaps may be surgically created defects or defects created by traumatic injury to the bone. Rafugen™ DBM is resorbed/remodeled and is replaced by host bone during the healing process.
Device Description
Rafugen™ DBM is a human bone allograft product containing human DBM (demineralized bone matrix), CMC (carboxymethyl cellulose), Starch and Glycerol. It is intended for use in filling bony voids or gaps of the skeletal system not intrinsic to the stability of the bony structure. Rafugen™ DBM is a ready-to use moldable gel formulation provided pre-filled in syringes of various volumes and is intended for single patient use. It is offered in six volumes: 0.25, 0.5, 1.0, 3.0, 5.0, and 10.0 cc. The Rafugen™ DBM can be either directly applied into the defect from the syringe, using the cap tip, or extruded for molding and insertion into the defect by hand.
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