BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CrossFT, Suture Anchor

    Reg #: 1054811 · FEI: 1000114185 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    42
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Sterigenics U.S. LLC
    Registration Number
    1054811
    FEI Number
    1000114185
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    502 Prairie Mine Rd
    City
    MULBERRY
    State
    FL
    ZIP
    33860
    Country
    US

    Regulatory Submissions

    510(k) Number
    K091549

    Owner / Operator

    Firm Name
    Sotera Health LLC
    Operator Number
    10029425
    Address
    2015 Spring Road, Suite 650
    City
    Oak Brook
    State
    IL
    Postal Code
    60523
    Country
    US
    Correspondent
    Karen Whaley-Krumins

    Products

    Device Name Product Code
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    CrossFT, Suture Anchor CrossFT, Suture Anchor w/ Needles ThRevo-FT, Suture Anchor ThRevo-FT, Suture Anchor w/ Needles Super Revo FT, Suture Anchor 4.5MM POPLOK SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES CROSSFT 4.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES THREVO-FT 5MM SUTURE ANCHOR W/ 3 HI-FI No. 2 (5 METRIC) SUTURES W/ NEEDLES CROSSFT 6.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES 6.5MM FT-ANCHOR MAN, 3X HIFI 6.5mm CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) POLYESTER SUTURES 4.5MM POPLOK SUTURE ANCHOR 2.8MM POPLOK SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE CROSSFT 6.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES CROSSFT 4.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES CROSSFT 4.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES 3.3MM SRS POPLOK, SUTURE ANCHOR WITH TWO NO. 0 (3.5 METRIC) HI-FI SUTURES 5MM SUPER REVO-FT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES CROSSFT 5.5MM SUTURE ANCHOR, W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/NEEDLES 5.5MM FT-ANCHOR MAN, 3X HIFI 6.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES 3.5MM POPLOK SUTURE ANCHOR WITH ONE NO. 2, (5 METRIC) HI-FI SUTURE 5MM THREVO-FT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES 6.5MM FT-ANCHOR MAN, 2X HIFI 4.5mm CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) POLYESTER SUTURES 6.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES 5.5mm CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) POLYESTER SUTURES 4.5MM FT-ANCHOR MAN, 2X HIFI 4.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES SUPER REVO-FT 5MM SUTURE ANCHOR W/ 2 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES 4.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES 5.5MM CROSSFT SUTURE ANCHOR WITH THREE NO. 2 (5 METRIC) HI-FI SUTURES 5.5MM CROSSFT SUTURE ANCHOR WITH TWO NO. 2 (5 METRIC) HI-FI SUTURES 4.5MM FT-ANCHOR MAN, 3X HIFI 5MM THREVO-FT SUTURE ANCHOR ONLY WITH THREE 2 HI-FI SUTURES 5.5MM FT-ANCHOR MAN, 2X HIFI 3.3MM SRS POPLOK, SUTURE ANCHOR WITH ONE NO. 2 (5 METRIC) HI-FI SUTURE 5MM SUPER REVO-FT SUTURE ANCHOR ONLY WITH TWO 2 HI-FI SUTURES CROSSFT 5.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES CROSSFT 4.5MM SUTURE ANCHOR, W/ 3 HI-FI NO. 2 (5 METRIC) SUTURES W/ NEEDLES 2.8MM SRS POPLOK, SUTURE ANCHOR WITH TWO NO. 0 (3.5 METRIC) HI-FI SUTURES 3.5MM POPLOK SUTURE ANCHOR

    Establishment Types

    Sterilize Medical Device for Another Party (Contract Sterilizer)