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510(k) Data Aggregation
K Number
K111001Device Name
STERILE STORM (R) OPERATING KIT
Manufacturer
Date Cleared
2011-05-17
(36 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
INTELLIGENT ORTHOPAEDICS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The STΦRM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur.
Device Description
The STΦRM™ Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.
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K Number
K070724Device Name
IOS EXTERNAL FIXATOR, MODEL 2-0-0
Manufacturer
Date Cleared
2007-05-16
(62 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
INTELLIGENT ORTHOPAEDICS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The IQS fixator is intended for use in the treatment of bone conditions including fracture fixation and other bone conditions which are amenable to treatment by the use of external fixation.
Device Description
The ids fixator construct comprises of a main body which incorporates a central portion with larger ends with three 10mm diameter holes in each to accommodate bone screws. It is available in two lengths - 70 mm and 110mm. A screw sleeve fits into each hole and the bone screw is passed through each sleeve and into the bone fragment through the skin. The bone screw is secured to the fixator using a grub screw (passing through the sleeve) and tightening onto the screw directly. The ids fixator is a single use device.
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K Number
K061607Device Name
STORM OPERATING KIT, MODEL 1-10-0
Manufacturer
Date Cleared
2006-07-18
(39 days)
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
INTELLIGENT ORTHOPAEDICS LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The STORM™ Operating Kit is used in conjunction with the STΦRM™ in the reduction and fixation of fractures of the lower leg or distal femur
Device Description
The STORM®® Operating Kit consists of two Kirschner wires with collets (diameter 2mm; one length 280mm, the other length 400mm), two self threading 4.5mm bone screws and a 3.2mm single use drill bit.
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