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510(k) Data Aggregation
K Number
K122503Device Name
PARALLAX BALLOON INFLATABLE BONE TAMP-10 MM BALLOON PARALLAX BALLOON INFLATABLE BONE TAMP-15 MM BALLOON PARALLAX BALLOON
Manufacturer
Date Cleared
2013-06-25
(313 days)
Product Code
Regulation Number
888.3027Why did this record match?
Applicant Name (Manufacturer) :
NEURO THERM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The NeuroTherm Parallax Balloon Inflatable Bone Tamp is intended to be used as a conventional bone tamp for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The Parallax Balloon Inflatable Bone Tamp is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cement indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Device Description
The NeuroTherm Parallax Balloon Inflatable Bone Tamp with an inflatable component at the distal end. The tamp is designed to compress cancellous bone and/or move cortical bone as it inflates. The catheter shaft contains an outer lumen for the tamp inflation and a central lumen for a stylet to facilitate catheter introduction. At full inflation volume, the balloon design allows for a uniform balloon that is concentric to the catheter shaft. The wire mandrel provides stiffness to the balloon catheter to facilitate insertion through the access cannula. The NeuroTherm Parallax Balloon Inflatable Bone Tamp may be used with FDA cleared balloon inflation syringes.
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