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

    Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology

    K Number: K172343 · Decision Oct 23, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    418
    Registration Numbers
    418
    Same Product Code
    890
    Applicant Total
    7
    Review Days
    82

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    Basic Information

    Device Name
    Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
    K Number
    K172343
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.3080
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rti Surgical, Inc.
    Date Received
    August 2, 2017
    Decision Date
    October 23, 2017
    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 Rti Surgical, Inc.

    K Number Device Name
    K253145 Pre-Sutured Tendon
    K241555 Moldable Bone Void Filler and Moldable Bone Void Filler + CCC
    K230036 Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
    K163673 Fortilink™-C with TETRAfuse™ 3D Technology
    K142070 FORTIVA PORCINE DERMIS, TUTOPLAST PORCINE DERMIS
    K132850 BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM