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

    SHARPOINT LUKENS BONE WAX

    K Number: K050292 · Decision Mar 9, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    22
    Review Days
    30

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    SHARPOINT LUKENS BONE WAX
    K Number
    K050292
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Specialties Corp
    Date Received
    February 7, 2005
    Decision Date
    March 9, 2005
    Product Code
    MTJ
    Advisory Committee
    Unknown
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MTJ Wax, Bone

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MTJ), ordered by most recent decision date.

    Permatage Flowable, Settable Hemostatic Bone Paste

    FDA 510(k)
    FDA Unclassified ·Unknown

    Montage- XT Settable, Resorbable Hemostatic Bone Putty

    FDA 510(k)
    FDA Unclassified ·Unknown

    MONTAGE Settable, Resorbable Hemostatic Bone Putty

    FDA 510(k)
    FDA Unclassified ·Unknown

    Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste

    FDA 510(k)
    FDA Unclassified ·Unknown

    Meril-Bonewax

    FDA 510(k)
    FDA Unclassified ·Unknown

    MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

    FDA 510(k)
    FDA Unclassified ·Unknown
    View all

    Other Clearances by Surgical Specialties Corp

    K Number Device Name
    K141625 POLYSYN SURGICAL SUTURE
    K141558 QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE
    K140227 MONODERM SURGICAL SUTURE
    K080985 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO)
    K080680 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF PDO (POLYDIOXANONE
    K071989 QUILL SELF-RETAINING SYSTEM (SRS) SYNTHETIC ABSORBABLE SURGICAL SUTURE MATERIAL
    K072028 QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF MONODERM
    K063680 SHARPOINT PDO (POLYDIOXANONE) SUTURES
    K053380 CONTOUR THREAD SYNTHETIC ABSORBABLE PDO BARBED SUTURE
    K052962 OPTIMIZED BARB DESIGN
    Search all 22 clearances from Surgical Specialties Corp →