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

    T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System

    K Number: K162358 · Decision Nov 1, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    16
    Review Days
    70

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    Basic Information

    Device Name
    T-PAL Spacer System, T-PAL Titanium Spacer System, SYNFIX Evolution System
    K Number
    K162358
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Synthes USA Products, LLC
    Date Received
    August 23, 2016
    Decision Date
    November 1, 2016
    Product Code
    MAX
    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
    MAX Intervertebral Fusion Device With Bone Graft, Lumbar

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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
    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
    Search all 16 clearances from Synthes USA Products, LLC →