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

    SYNTHES HEMOSTATIC BONE PUTTY (HBP)

    K Number: K103822 · Decision May 19, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    41
    Applicant Total
    16
    Review Days
    140

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    Basic Information

    Device Name
    SYNTHES HEMOSTATIC BONE PUTTY (HBP)
    K Number
    K103822
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA Products, LLC
    Date Received
    December 30, 2010
    Decision Date
    May 19, 2011
    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

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    Other Clearances by Synthes USA Products, LLC

    K Number Device Name
    K180541 DePuy Synthes 2.0 mm Quick Insertion Screws
    K170818 Craniomaxillofacial Distraction System (CMFD)
    K162594 Craniomaxillofacial Distraction System (CMFD)
    K170654 USS System
    K161616 DePuy Synthes 4.0 mm and 4.5 mm Cortex Screws, DePuy Synthes 2.4 mm Cannulated Screws, DePuy Synthes 3.5 mm and 4.0 mm Cannulated Screws, DePuy Synthes 4.5 mm Cannulated Screws, DePuy Synthes 6.5 mm Cannulated Screws, DePuy Synthes 7.0 mm and 7.3 mm Cannulated Screws, DePuy Synthes 1.5 mm Headless Compression Screws, DePuy Synthes 2.4 mm Headless Compression Screws, DePuy Synthes 3.0 mm Headless Compression Screws, DePuy Synthes 4.5 mm and 6.5 mm Headless Compression Screw
    K162358 T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
    K151276 DePuy Synthes T-PAL Ti Spacer
    K143285 Mandible External Fixator - MR Conditional
    K142838 Synapse Occipital-Cervical-Thoracic (OCT) System
    K141897 SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEM
    Search all 16 clearances from Synthes USA Products, LLC →