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510(k) Data Aggregation
K Number
K090091Device Name
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
Manufacturer
Date Cleared
2009-02-01
(18 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
MYLAD ORTHOPEDIC SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
Device Description
The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a carbon fiber composite guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.
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K Number
K081356Device Name
OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM
Manufacturer
Date Cleared
2008-07-09
(56 days)
Product Code
Regulation Number
888.3020Why did this record match?
Applicant Name (Manufacturer) :
MYLAD ORTHOPEDIC SOLUTIONS, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OlecraNail™ Intramedullary Fixation System and accessories are intended for the surgical fixation of all fractures and surgical osteotomies of the proximal ulna in the acute or chronic setting.
Device Description
The OlecraNail™ intramedullary rod is a solid bore, stainless steel, tapered rod that is inserted into a pre-drilled hole into the medullary canal of the proximal ulna. Once the device is in place, a combination stainless steel/polyphenylsulfone guide is used to drill into the bone and insert several screws through the bone and rod to secure all bone fragments and lock the rod into position. During this process, compression at the fracture site may be obtained by manually turning a knob to activate the compression mechanism. After all screws are placed, the guide may then be detached using a break-away mechanism.
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