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

    SeaSpine® Daytona® Small Stature Spinal System

    K Number: K163604 · Decision Mar 9, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    407
    Registration Numbers
    407
    Same Product Code
    900
    Applicant Total
    66
    Review Days
    78

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    Basic Information

    Device Name
    SeaSpine® Daytona® Small Stature Spinal System
    K Number
    K163604
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3070
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SeaSpine Orthopedics Corporation
    Date Received
    December 21, 2016
    Decision Date
    March 9, 2017
    Product Code
    NKB
    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
    NKB Thoracolumbosacral Pedicle Screw System

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    Other Clearances by SeaSpine Orthopedics Corporation

    K Number Device Name
    K250908 Virata Spinal Fixation System
    K243659 FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
    K242273 Cove Putty, OsteoCove Putty
    K241466 Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System
    K240566 Reef L Interbody System; WaveForm L Interbody System
    K232566 NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System
    K233694 Meridian Interbody System; WaveForm A Interbody System
    K233414 Shoreline ACS Interbody System; Shoreline RT Interbody System
    K232668 Cove Strip, OsteoCove Strip
    K231030 Cove Putty, OsteoCove Putty
    Search all 66 clearances from SeaSpine Orthopedics Corporation →