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

    Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )

    K Number: K230036 · Decision Jun 23, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    242
    Registration Numbers
    242
    Same Product Code
    173
    Applicant Total
    7
    Review Days
    178

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Pre-Sutured Tendon (4561SC / Single Strand); Pre-Sutured Tendon (4564SC / Quadruple Strand )
    K Number
    K230036
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.5000
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rti Surgical, Inc.
    Date Received
    December 27, 2022
    Decision Date
    June 23, 2023
    Product Code
    GAT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GAT Suture, Nonabsorbable, Synthetic, Polyethylene

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GAT), ordered by most recent decision date.

    Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HyperSuture All Green Extension Line

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Meniscus Versaflex

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Pre-Sutured Tendon

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ProZip Knotless Implant

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PowerKnot High Strength Sutures

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    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
    K172343 Fortilink® Interbody Fusion (IBF) System with TETRAfuse® 3D Technology
    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