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

    IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP

    K Number: K024199 · Decision Mar 14, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    139
    Registration Numbers
    139
    Same Product Code
    335
    Applicant Total
    9
    Review Days
    84

    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
    IMMIX THIN FILM, MODELS: PSS-004-S, PSS-004-SP, PSS-004-M, PSS-004-MP, PSS-004-L, PSS-004-LP
    K Number
    K024199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Osteobiologics, Inc.
    Date Received
    December 20, 2002
    Decision Date
    March 14, 2003
    Product Code
    FTL
    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
    FTL Mesh, Surgical, Polymeric

    Similar 510(k) Clearances

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

    ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030)

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

    Parietene™ Flat Sheet Mesh

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

    Onflex™ Mesh

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

    Bard® Mesh; Bard® Mesh Pre-Shaped

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

    Parietene™ Macroporous Mesh (PPM5050 )

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

    Bard Soft Mesh; Bard Soft Mesh Pre-Shaped

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

    Other Clearances by Osteobiologics, Inc.

    K Number Device Name
    K051656 OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM
    K041382 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    K043172 TRUGRAFT BGS SYRINGE, MODEL 600-041
    K040047 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE
    K033707 POLYGRAFT TCP GRANULES, CUBES, BLOCKS, PLUGS, WEDGES, MODELS 600-023-XX, 600-025-XX, 600-026-XX, 600-022-XX, 600-027-XX
    K032673 IMMIX PLASTIFILM
    K030288 POLYGRAFT BONE GRAFT SUBSTITUTE
    K013429 ACTAEON PROBE