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510(k) Data Aggregation
K Number
K011373Device Name
INSTRUMENT DAMPING PORT
Manufacturer
MEDCANICA, INC.
Date Cleared
2001-10-12
(161 days)
Product Code
DRC
Regulation Number
870.1390Why did this record match?
Applicant Name (Manufacturer) :
MEDCANICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K011349Device Name
INTERCOSTAL LOCKABLE-DIRECTABLE PORT
Manufacturer
MEDCANICA, INC.
Date Cleared
2001-10-05
(156 days)
Product Code
DRC
Regulation Number
870.1390Why did this record match?
Applicant Name (Manufacturer) :
MEDCANICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K994232Device Name
PHALANGEAL FIXATION SYSTEM
Manufacturer
MEDCANICA, INC.
Date Cleared
2000-03-01
(76 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MEDCANICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Phalangeal Fixation System is indicated for the fixation of transverse or short oblique fractures of proximal phalanx of the fingers.
Device Description
The PFS is a single use, non-toxic, disposable, sterile device. The PFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube.
Prior to use, the implantable pin assembly is nested in the cannulated awl assembly. The cannulated awl assembly has a trocar point. The implantable pin has a blunt point that is positioned just behind the trocar point of the cannulated awl. The sharp point of the cannulated awl assembly is passed through a small incision. A hole is drilled into the Phalangeal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the cannulated awl handle is held stationary while the implantable pin is then advanced distally from the base of the phalangeal bone.
The awl handle is then withdrawn and removed for advancement of the implantable pin. Multiple pins, usually two, are implanted in the manner previously described. The pins are placed in a arrangement to minimize radial movement.
The implantable pin(s) is then cut at the taper near the proximal end of the pin. Using the bending tube end of the exchange guide the implantable pin is bent to 90° with the apex of the bend at the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed.
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K Number
K991486Device Name
ULTRA-CBX
Manufacturer
MEDCANICA, INC.
Date Cleared
1999-11-05
(191 days)
Product Code
DWZ
Regulation Number
870.4075Why did this record match?
Applicant Name (Manufacturer) :
MEDCANICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endomyocardial Biopsy Forceps are designed for endomyocardial biopsies.
Device Description
The EMB is sterile, single use, radiopaque, disposable device that is delivered non-toxic and non-pyrogenic. The device is transvascularly deployed to the right ventricle of the heart for the acquisition of endomyocardial tissue samples Typically, the approach is made from the jugular vein or femoral arteries. The EMB consists of 4 major components: the moveable handle, end-effectors (jaws), core wire, and sheath. The core wire is attached to the handle. Moving the handle opens and closes the jaws.
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K Number
K991064Device Name
METACARPAL FIXATION SYSTEM
Manufacturer
MEDCANICA, INC.
Date Cleared
1999-06-23
(84 days)
Product Code
HTY, DAT
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
MEDCANICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Metacarpal Fixation System is indicated for the fixation of transverse or short oblique fractures of the diaphysis or diaphyseal-metaphyseal junction of metacarpal bones.
Device Description
The MFS is a sterile, single use, disposable device that is delivered non-toxic. The MFS consists of the Cannulated Awl Assembly, the Implantable Pin Handle Assembly, and Exchange Guide and Bend Tube. Prior to use the implantable pin assembly is nested in the cannulated awl assembly. The cannulated awl assembly has a trocar point. The implantable pin has a blunt point that is positioned just behind the trocar point of the cannulated awl. The sharp point of the cannulated awl assembly is passed through a small incision. A hole is drilled into the metacarpal bone by twisting the assembled handles back and forth. After gaining access to the intramedullary space, the cannulated awl handle is held stationary while the implantable pin is then advanced distally from the base of the metacarpal bone. The awl handle is then withdrawn and removed for advancement of the implantable pin. The implantable pin is then cut adjacent to the pin handle. Using the bending tube end of the exchange guide and bend tube, the implantable pin is bent to 90° with the apex of the implantable pin insertion site. The pin is trimmed so that the end is below the skin. The small piece remaining will facilitate removal of the implantable pin subsequent to healing. The implantable pin will remain implanted for approximately six weeks. Upon healing of the fracture, the implantable pin is percutaneously removed. In the event that it is desired to reform the implantable pin or implant a smaller pin, this may be accomplished without loosing access to the medullary canal. The exchange guide is advanced along the implantable pin into the medullar space. Once the medullar space is accessed, the pin is removed. Another pin may be placed into the medulla by inserting it into the groove of the exchange guide. After the pin has been inserted into the medullar space, remove the exchange guide.
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