BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TWINFIX PK FT 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue and Cobraid Black)

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    86
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    SMITH & NEPHEW INC.
    Registration Number
    1219602
    FEI Number
    1219602
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    ENDOSCOPY, 120 FORBES BLVD. SUITE 150 / 130 FORBES BLVD.
    City
    MANSFIELD
    State
    MA
    ZIP
    02048
    Country
    US

    Regulatory Submissions

    510(k) Number
    K152566

    Owner / Operator

    Firm Name
    Smith & Nephew, Inc.
    Operator Number
    1020279
    Address
    2875 Railroad Street
    City
    Pittsburgh
    State
    PA
    Postal Code
    15222
    Country
    US
    Correspondent
    Lisa Ewing

    Products

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

    Proprietary Names

    TWINFIX PK FT 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue and Cobraid Black) BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Black) TWINFIX Ultra PK 5.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (White/Cobraid Blue) TWINFIX Ultra Ti 5.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue & Cobraid Black) HEALICOIL PK 5.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) TWINFIX Ultra PK 6.5 MM Suture Anchor w/ Three ULTRABRAID Sutures FOOTPRINT Ultra PK Suture Anchor, 5.5 MM TWINFIX PK FT 5.5 MM Suture Anchor w/ Two ULTRABRAID Sutures BIORAPTOR Knotless Suture Anchor, Hip TWINFIX Ultra Ti 4.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue & Cobraid Black) TWINFIX Ultra PK 5.5 MM Suture Anchor w/Two ULTRABRAID Sutures (Blue/Blue Cobraid) BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Blue) TWINFIX PK FT 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures w/Awl HEALICOIL PK 4.5 MM Suture Anchor with Two ULTRABRAID Sutures (Blue/Cobraid Blue) TWINFIX 5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED DURABRAID SUTURES STERILE TWINFIX PK FT 5.5MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue and Cobraid Black) BIORAPTOR Curved 2.3 PK Suture Anchor w/ One ULTRABRAID Suture (Cobraid Blue) TWINFIX PK FT 5.5 MM Suture Anchor w/ Three ULTRABRAID Sutures BIORAPTOR 2.3 PK SUTURE ANCHOR WITH ONE No.2 PRELOADED ULTRABRAID SUTURE, COBRAID BLACK/WHITE TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULT TWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES, STERILE TWINFIX Ti 6.5 Suture Anchor w/ Two DURABRAID Sutures TWINFIX Ultra PK 6.5 MM Suture Anchor w/Two ULTRABRAID Sutures (Blue/Blue Cobraid) HEALICOIL PK 4.5MM SUTURE ANCHOR WITH TWO MINITAPE SUTURES (BLUE, COBRAID WHITE) HEALICOIL PK 5.5MM SUTURE ANCHOR WITH THREE MINITAPE SUTURES (BLUE, COBRAID WHITE, COBRAID BLUE) TWINFIX 6.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED DURABRAID SUTURES, STERILE TWINFIX Ti 3.5 Suture Anchor w/ Two DURABARID Sutures TWINFIX Ultra PK 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (White/Cobraid Blue) TWINFIX Ultra Ti 4.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue & White) FOOTPRINT PK 6.5 MM Suture Anchor TWINFIX ULTRA 6.5 MM PK ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE HEALICOIL SA PK 5.5MM W/3 UB-BL CBBL LT TWINFIX 2.8 MM TITANIUM SUTURE ANCHOR WITH ONE No.2 PRELOADED DURABRAID SUTURE STERILE TWINFIX 2.8 MM TITANIUM SUTURE ANCHOR WITH ONE No.2 PRELOADED ULTRABRAID SUTURE, STERILE TWINFIX PK FT 6.5 ANCH W/3 ULTRABRAID TWINFIX Ultra PK 4.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (White/Cobraid Blue) TWINFIX Ultra Ti 5.5 MM Suture Anchor w/ Three ULTRABRAID Sutures TWINFIX PK FT 6.5 W/3 ULTRABRAID & AWL TTWINFIX 3.5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED DURABRAID SUTURES STERILE TWINFIX Ti 2.8 Suture Anchor w/One ULTRABRAID Suture HEALICOIL PK 5.5 MM Suture Anchor with Three ULTRABRAID Sutures (Blue/Cobraid Blue/Cobraid Black) BIORAPTOR Knotless Suture Anchor TWINFIX Ultra Ti 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue & White) TWINFIX PK FT 5.5 W/2 ULTRABRAID CO-BR TWINFIX Ti 6.5 Suture Anchor w/ Two ULTRABRAID Sutures BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLUE TWINFIX PK FT 6.5 W/2 ULTRABRAID & AWL BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (Cobraid Black) TWINFIX Ultra PK 4.5 MM Suture Anchor w/Two ULTRABRAID Sutures (Blue/Blue Cobraid) TWINFIX 5.5 MM PK FT ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, WHITE ULTRABRAID, STERILE, WITH AWL TWINFIX ULTRA 4.5 MM PK ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE TWINFIX Ti 2.8 Suture Anchor w/One DURABRAID Suture HEALICOIL PK 5.5 MM Suture Anchor with Two ULTRABRAID Sutures (Blue/Cobraid Blue) BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID Suture (White) TWINFIX Ultra PK 5.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue/Cobraid Black) TWINFIX PK FT 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures TWINFIX Ultra Ti 6.5 MM Suture Anchor w/ Three ULTRABRAID Sutures TWINFIX Ti 5 Suture Anchor w/ Two ULTRABRAID Sutures TWINFIX Ultra PK 5.5 MM Suture Anchor w/ Three ULTRABRAID Sutures TWINFIX Ultra Ti 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue & Cobraid Black) TWINFIX Ultra PK 4.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue/Cobraid Black) TWINFIX PK FT 6.5 MM Suture Anchor w/ Three ULTRABRAID Sutures TWINFIX Ultra PK 6.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue/Cobraid Black) TWINFIX 5.5 MM PK FT ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, WHITE ULTRABRAID, STERILE TWINFIX 5.5 MM PK FT ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK, STERILE, WITH AWL TWINFIX Ti 5 Suture Anchor w/ Two DURABRAID Sutures FOOTPRINT Ultra PK Suture Anchor, 4.5 MM TWINFIX Ti 3.5 Suture Anchor w/ Two ULTRABRAID Sutures TWINFIX Ultra Ti 5.5 MM Suture Anchor w/ Two ULTRABRAID Sutures (Cobraid Blue & White) TWINFIX PK FT 6.5 W/2 UB CO-BRAID TWINFIX ULTRA 6.5 MM PK ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK STERILE BIORAPTOR CURVED 2.3 PK SUTURE ANCHOR WITH ONE 38 INCH ULTRABRAID No. 2 SUTURE COBRAID BLACK SHOULDER 2.3 MM BIORAPTOR PK SUTURE ANCHOR WITH ONE ULTRABRAID No.2 WHITE, SUTURE, STERILE TWINFIX ULTRA 4.5 MM PK ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE HEALICOIL SA PK 5.5mm W/2 UB-BL, CBRD BL "BIORAPTOR KNOTLESS SUTURE ANCHOR, SHOULDER CLOSE" TWINFIX 5.5 MM PK FT ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK, STERILE HEALICOIL SA PK 4.5MM W/2 UB-BL CBRD BL TWINFIX 5 MM TITANIUM SUTURE ANCHOR WITH TWO No.2 PRELOADED ULTRABRAID SUTURES ONE ULTRABRAID WHITE SUTURE AND ONE ULT TWINFIX ULTRA 5.5 MM PK ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE FOOTPRINT 6.5 MM PK SUTURE ANCHOR TWINFIX ULTRA 6.5 MM PK ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE TWINFIX ULTRA 5.5 MM PK ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK STERILE BIORAPTOR KNOTLESS SUTURE ANCHOR TWINFIX TI 2.8 HS SUTR ANCHR W/2 28 DUR TWINFIX PK FT 6.5 ANCH W/2 ULTRABRAID

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device