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510(k) Data Aggregation

    K Number
    K180807
    Device Name
    Celling Aspiration Needle
    Date Cleared
    2018-05-24

    (57 days)

    Product Code
    Regulation Number
    876.1075
    Why did this record match?
    Applicant Name (Manufacturer) :

    SpineSmith Holdings, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Celling Aspiration Needle is intended for use in aspirating bone marrow.
    Device Description
    The Celling Aspiration Needle is a single-use aspiration needle comprised of a stainless steel cannula with a molded plastic handle, and a stainless steel stylet with a molded plastic handle which mates with the cannula handle when the stylet is inserted through the cannula. While holding the mated handles, the user rotates the needle using a clockwise-counter clockwise motion while applying pressure on the bone. The needle bores into the marrow cavity. Once there the stylet is removed and aspiration is accomplished by attaching a luer syringe (not included) to the needle and applying negative pressure.
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    K Number
    K141537
    Device Name
    IN:C2 SPINAL FIXATION SYSTME
    Date Cleared
    2014-11-25

    (168 days)

    Product Code
    Regulation Number
    888.3080
    Why did this record match?
    Applicant Name (Manufacturer) :

    SPINESMITH HOLDINGS, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IN:C2 Spinal Fixation System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. IN:C2 is a stand-alone device intended to be used with an anterior cover plate and a minimum two provided bone screws angled both cephalad and caudal with a minimum of one screw into each vertebral body. The implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral cage.
    Device Description
    The IN:C2 System consists of a 'U' shaped PEEK block in multiple footprint configurations and heights. The PEEK implants contain a titanium marker intended to verify position radiologically. The IN:C2 is a stand-alone system, intended for use with its cover plate assembly and two titanium bone screws provided. The IN:C2 implant is intended to be implanted via an open anterior approach. The anterior cover plate assembly attaches to the anterior most portion of the device, and includes housing features for placement of two bone screws angled cephalad and caudal. The cover plate assembly and integrated screws are supplemental fixation.
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