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510(k) Data Aggregation
K Number
K103231Device Name
KYPHON INFLATION SYRINGE
Manufacturer
Date Cleared
2011-01-24
(84 days)
Regulation Number
888.1100Why did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC SPINE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Kyphon® Inflation Syringe is intended to be used to inflate and deflate inflatable devices (including Inflatable Bone Tamps) and to measure the pressure within the inflatable device during the procedure.
Device Description
The Kyphon® Inflation Syringe consists of a syringe barrel; a threaded plunger assembly with a depress-release handle; a digital display that provides pressure readout; an outer shell assembly that retains the internal components; a flexible tubing designed to withstand high inflation pressures; and a weighted swivel-luer for connection to the inflatable device (including Inflatable Bone Tamps). The device is designed to generate and monitor pressures up to 700psi (providing the user the option to be able to select the Maximum Inflation Pressure of 400psi or 700psi depending on the inflatable device being used). The Locking Syringe (to be packaged together with the Inflation Syringe) is a 30ml polycarbonate syringe and is included for preparation of the inflatable device, as necessary. A V-Klip™ (available as part of the 2 Pack configuration) holds two Kyphon Inflation Syringes for concurrent dual-syringe operation.
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K Number
K101765Device Name
KYPHON ANCHOR FACET SCREW SYSTEM
Manufacturer
Date Cleared
2010-10-22
(121 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
MEDTRONIC SPINE LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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