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510(k) Data Aggregation

    K Number
    K962757
    Device Name
    J.B.S. SPINE SYSTEM WITH PEDICLE SCREWS - ADDITIONAL COMPONENTS - SCREWS, LINKING PLATES, HOOKS AND ROD CLAMP
    Manufacturer
    J.B.S., S.A.
    Date Cleared
    1996-09-25

    (71 days)

    Product Code
    MNH
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    J.B.S., S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    When wed as a non cervical hook and sarel services in indicated for we in prisents with degenerative discover (discosenic back pain with deserentian of the discomplies to racked studies), spondegical sociosis, spinel starts spinel starts with winnely falled back suppens, and frances. Villem wed as credicte screens (a) lawing sever sports (a) lawing sever sport 4) at the L.S.S) joint, , who are receiving fusion using anto cone watt only, (c) who are having the device for attacked to the lumber and (d) who are lasing the clerine "tenoved after development of a stid fision mess The simple, is intended for ossein five levels 17 through S. The Searl Pares are interned for posterior sacral fixation at S1 and S2. Levels of pedicle screw fivation are posterior from levels L3 to through S1 only.
    Device Description
    The J.S.Spine System @ inplans are station of the stablic the hunter and torners were to promote insion. The System is to be removed aller fision occurs. The JBS. Spine Systems, sazal plates, pedicle screws, reds, pedicle and laminer hooks and linking plates. J.B.S. has both firm rod systems. The inqlant are composed of surgical implant timinon, T.6ALAVELL, accoming to ASTM-136-92. Instruments to implat the IB.S. Spine System are made of ZOC'l stainless steel source to ATM grace 400 staries see) with a polyna handle, ar surgical implant titanium, Ti 6Al 4V EI I .
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    K Number
    K955864
    Device Name
    J.B. S. C1-C2 CLAMP
    Manufacturer
    J.B.S., S.A.
    Date Cleared
    1996-03-15

    (79 days)

    Product Code
    KWP
    Regulation Number
    888.3050
    Why did this record match?
    Applicant Name (Manufacturer) :

    J.B.S., S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fixation of C1-C2 in case of fracture or multi-operated back.
    Device Description
    The J.B.S. Posterior C1-C2 Clamp System is a single-use. temporary device used for fixation of the C1-C2 vertebrae. The System is to be removed after fusion occurs. It consists of a cervical hook, a superior hook, a linking screw and a locking screw. All these components are made of surgical implant titanium with the composition Ti-6AL-4V ELI according to ASTM-136-92 or ISO 5832-3-90.
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    K Number
    K953881
    Device Name
    SPINE SYSTEM SACRAL PLATE
    Manufacturer
    J.B.S., S.A.
    Date Cleared
    1996-02-21

    (187 days)

    Product Code
    MNH
    Regulation Number
    888.3070
    Why did this record match?
    Applicant Name (Manufacturer) :

    J.B.S., S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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