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510(k) Data Aggregation

    K Number
    K162321
    Device Name
    EasyClip Xpress
    Manufacturer
    RESTORE SURGICAL LLC dba Instratek
    Date Cleared
    2017-02-10

    (175 days)

    Product Code
    JDR
    Regulation Number
    888.3030
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESTORE SURGICAL LLC dba Instratek

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EasyClip XPress Staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
    Device Description
    EasyClip Xpress is comprised of superelastic bone staples, as well as associated instrumentation required for implantation of the staples.
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    K Number
    K161778
    Device Name
    ToeTac™ 10° Hammertoe Fixation System
    Manufacturer
    RESTORE SURGICAL LLC DBA INSTRATEK
    Date Cleared
    2016-11-22

    (146 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESTORE SURGICAL LLC DBA INSTRATEK

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.
    Device Description
    The Instratek ToeTac™ 10° Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver, as well as a single packaged implant.
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    K Number
    K150443
    Device Name
    ToeTac Hammertoe Fixation System
    Manufacturer
    RESTORE SURGICAL LLC dba Instratek
    Date Cleared
    2015-06-04

    (104 days)

    Product Code
    HWC
    Regulation Number
    888.3040
    Why did this record match?
    Applicant Name (Manufacturer) :

    RESTORE SURGICAL LLC dba Instratek

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ToeTac™ Hammertoe Fixation System indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
    Device Description
    The Instratek ToeTac™ Hammertoe Fixation System includes a threaded PEEK implant for bone fixation and a set of instruments used for implant site preparation and delivery. The device is offered in a sterile packaged kit that contains the implant, bone preparation instrumentation and a driver.
    Ask a Question

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