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

    NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY

    K Number: K102018 · Decision Sep 23, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    39
    Registration Numbers
    39
    Same Product Code
    43
    Applicant Total
    16
    Review Days
    66

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    Basic Information

    Device Name
    NORIAN REINFORCED, NORIAN REINFORCED FAST SET PUTTY
    K Number
    K102018
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5300
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA Products, LLC
    Date Received
    July 19, 2010
    Decision Date
    September 23, 2010
    Product Code
    GXP
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GXP Methyl Methacrylate For Cranioplasty

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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
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