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Found 4 results
510(k) Data Aggregation
K Number
K091806Device Name
POGO SCREW INSTRUMENTATION TRAY
Manufacturer
FXDEVICES
Date Cleared
2010-02-22
(249 days)
Product Code
KCT, POG
Regulation Number
880.6850Why did this record match?
Applicant Name (Manufacturer) :
FXDEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POGO Screw Instrumentation Tray is intended for the protection, organization and delivery to the surgical field of the POGO Screw Instrumentation Set.
The trays are not intended to maintain sterility by themselves. They are designed to facilitate the pre-vacuum autoclave sterilization process when used in conjunction with a wrapping material (FDA cleared sterilization wrap). Wrapping materials are designed to allow air removal, steam penetration/evacuation and maintain the sterility of the internal components.
Sterilization Cycle Parameters
Method: Steam Cycle: Pre-vacuum Temperature: 132ºC Exposure: 4 minutes Drying Time: 30 minutes
or
Method: Steam Cycle: Gravity Temperature: 132ºC Exposure: 15 minutes Drying Time: 80 minutes
Device Description
The POGO Screw Instrumentation Tray is a custom autoclavable, compartmentalized, and perforated tray with a locking lid. It is intended to enclose and protect medicel device instrumentation, and to facilitate the sterilization process by allowing sterilant peneration and air removal. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap.
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K Number
K092189Device Name
POGO SCREW
Manufacturer
FXDEVICES
Date Cleared
2009-09-18
(59 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FXDEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
Device Description
Dovice Bels.ipness are comprised of various size cannulated screws for the fixation of bone fractures. POGO screws are made of 316LVM Stainless Steel conforming to ASTM F138. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
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K Number
K080649Device Name
POGO SCREW
Manufacturer
FXDEVICES
Date Cleared
2008-11-25
(263 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FXDEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The POGO Screw is indicated for use in the general management of fractures and reconstructive surgery.
Device Description
The POGO Screws are comprised of various size cannulated screws for the fixation of bone fractures. The components are manufactured from 316 surgical stainless steel. The screws are available in various sizes from 55mm to 130mm in length. They are provided sterile and also non sterile to be sterilized by the user prior to use.
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K Number
K070393Device Name
LAGWIRE SYSTEM
Manufacturer
FXDEVICES
Date Cleared
2007-05-04
(84 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
FXDEVICES
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lagwire is indicated for use in the general management of fractures and reconstructive surgery.
Device Description
The Lagwire fixation system consists of two (2) main components, a wire and a cap. The Lagwire materials are Titanium 6Al-4V alloy, which meets the requirements of ASTM F-136. It is available as 4.5 mm diameter device and is obtainable in various length ranges. The Lagwire is provided sterile and intended for single use only.
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