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510(k) Data Aggregation

    K Number
    K971583
    Device Name
    MEDPOR OCULAR SCREW AND ACCEOSSORIES
    Manufacturer
    POREX TECHNOLOGIES CORP.
    Date Cleared
    1997-06-30

    (61 days)

    Product Code
    MQU
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    POREX TECHNOLOGIES CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MCP® is indicated for patients with MEDPOR® Ocular Implants, who desire improved prosthetic eye motility via direct coupling of the implant to the prosthetic eye. Primary placement of the-MGP® may occur during the initial … reconstruction procedure, following attachment of the extraocular muscles to the ocular implant but before closing the Tenon's capsule and the conjunctiva layer. Secondary placement of the MCP may occur typically 3-6 months post enucleation after the ocular implant has become vascularized.
    Device Description
    #### Titanium Screw The screw is intended for single patient use. The Titanium Screw is composed of #6A1-4V ELI titanium which meets ASTM Standard F136-92. Three head sizes of 4.6 mm, 3.5 mm, and 2.5 mm will be available. The screw head contains a square hole to mate with the driver. The screw shaft and thread pattern is the same for all three head sizes. The ocular screw is supplied non-sterile. #### Screwdriver The Screwdriver is manufactured of 316 stainless steel. The screwdriver tip is designed to mate with the square hole in the head of the titanium screw. The screwdriver is supplied non-sterile and is intended to be re-usable. #### Drill Bit The Drill Bit is a 1 mm diameter, 316 stainless steel, twist drill bit to be used for drilling a pilot hole for the screw. The Drill Bit is supplied non-sterile, and is intended to be re-usable.
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    K Number
    K960859
    Device Name
    MEDPOR OCULAR PEG SYSTEM AND ACCESSORIES
    Manufacturer
    POREX TECHNOLOGIES CORP. OF GEORGIA
    Date Cleared
    1996-05-29

    (89 days)

    Product Code
    HPZ
    Regulation Number
    886.3320
    Why did this record match?
    Applicant Name (Manufacturer) :

    POREX TECHNOLOGIES CORP. OF GEORGIA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Not Found
    Device Description
    The MEDPOR® Ocular Peg and Sleeve and Accessories consist of two HDPE (High Density Polyethylene) Pegs, and an HDPE Sleeve with the necessary associated manual surgical instruments. The pegs and sleeve will be sold as a package, supplied sterile. All other components will be supplied separately, non-sterile. The associated surgical instruments include an Ocular Implant Clamp for holding the implant during the procedure, a sleeve driver for screwing the sleeve into the implant, and three drill bits for drilling the hole for the peg or peg and sleeve.
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