Profile: Skeletal Kinetics LLC, develops, manufactures and markets Callos® bone void filler. It is a proprietary calcium phosphate bone fixation cement designed for use in regions of compromised cancellous bone resulting from traumatic fractures. It can be used independently or together with conventional orthopedic fixation hardware devices such as implantable plates, screws, rods and wires. It is biocompatible, and remodels via cell-mediated processes in a mechanical stress-directed fashion, instead of dissolving away before bone infilling can occur.
FDA Registration Number: 3003890476
5 Products/Services (Click for related suppliers)
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| • Calcium Compound Bone Void Filler (FDA Code: MQV / 888.3045) A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. |
| • Calcium Phosphate Bone Fixation Cements |
| • Cement Dispenser (FDA Code: KIH / 888.4200) A cement dispenser is a nonpowered syringe-like device intended for use in placing bone cement (888.3027) into surgical sites. |
| • Internal Chin Prosthesis (FDA Code: FWP / 878.3550) A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin. |
| • Methyl Methacrylate for Cranioplasty (FDA Code: GXP / 882.5300) Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect. |