BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PIONEER SURGICAL NANOSS BVF-E

    K Number: K091031 · Decision Nov 17, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    491
    Applicant Total
    50
    Review Days
    221

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    Basic Information

    Device Name
    PIONEER SURGICAL NANOSS BVF-E
    K Number
    K091031
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3045
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pioneer Surgical Technology
    Date Received
    April 10, 2009
    Decision Date
    November 17, 2009
    Product Code
    MQV
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MQV Filler, Bone Void, Calcium Compound

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    Other Clearances by Pioneer Surgical Technology

    K Number Device Name
    K110561 FORTROSS BONE VOID FILLER
    K101790 QUANTUM SPINAL SYSTEM, QUANTUM MIS
    K101525 PIONEER SPINOUS PROCESS FUSION PLATE
    K093692 QUANTUM/ STREAMLINE SPINAL SYSTEM MODEL 02-SERIES AND 10-SERIES
    K093771 QUANTUM/STREAMLINE TL MIS SPINAL SYSTEM
    K100708 PIONEER ANTERIOR CERVICAL PLATE MODEL 24-SERIES
    K100361 NANOSS BONE VOID FILLER
    K092295 PIONEER POSTERIOR CERVICO-THORACIC SYSTEM
    K083449 E-MATRIX GRAFT BONE EXTENDER
    K090222 PIONEER LUMBAR PLATE SYSTEM
    Search all 50 clearances from Pioneer Surgical Technology →