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

    DePuy Synthes 2.0 mm Quick Insertion Screws

    K Number: K180541 · Decision Nov 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    659
    Registration Numbers
    659
    Same Product Code
    1058
    Applicant Total
    16
    Review Days
    265

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    Basic Information

    Device Name
    DePuy Synthes 2.0 mm Quick Insertion Screws
    K Number
    K180541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3040
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA Products, LLC
    Date Received
    March 1, 2018
    Decision Date
    November 21, 2018
    Product Code
    HWC
    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
    HWC Screw, Fixation, Bone

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    Other Clearances by Synthes USA Products, LLC

    K Number Device Name
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    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
    K133698 SYNAPSE SYSTEM
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