BEUDAMED
    FDA Registration Active 🇺🇸 United States

    TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE

    Reg #: 1219602 · FEI: 1219602 · Expires 2025
    View on FDA
    Products
    5
    Proprietary Names
    83
    Establishment Types
    1
    Classifications
    5

    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
    K151105

    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, Biodegradable, Soft Tissue MAI
    Staple, Fixation, Bone JDR
    Screw, Fixation, Bone HWC
    Suture, Nonabsorbable, Synthetic, Polyethylene GAT
    Fastener, Fixation, Nondegradable, Soft Tissue MBI

    Proprietary Names

    TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE TWINFIX AB 6.5 SUTR ANCH W/2 38 ULTRAB TWINFIX AB 6.5 SUTR ANCHR W/2 38 DURABRA TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK TWINFIX AB 5 SUTR ANCHR W/2 38 DURAB OSTEORAPTOR 2.3 W 1UB II BLUE TWINFIX ULTRA 4.5 MM POLY L LACTIC ACID-HA SUTURE ANCHOR WITH TWO No.2 ULTRABRAID SUTURES BLUE, BLUE-COBRAID WITH NEEDLE TWINFIX ULTRA 4.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE TWINFIX ULTRA 6.5 MM POLY L LACTIC ACID-HA SUTURE ANCHOR WITH TWO No.2 ULTRABRAID SUTURES BLUE, BLUE-COBRAID WITH NEEDLE TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE ULTRA FAST-FIX AB Curved Needle Delivery System TwinFix AB 5 Suture Anchor w/Two 38” UltraBraid Sutures (#2) TwinFix AB 6.5 Suture Anchor w/Two UltraBraid Sutures (#2) & 5 Threaded Dilator ULTRA FAST-FIX AB Delivery System Reverse Curved TwinFix AB 6.5 Preloaded Suture Anchor with UltraBraid Suture and Needles w/Threaded Dilator OSTEORAPTOR™ 2.9 Suture Anchor w/ULTRABRAID™ (#2) Suture (cobraid blue) BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures and Needles OSTEORAPTOR™ 2.9 Suture Anchor w/1 ULTRABRAID™ (#2) Suture (white) TwinFix AB 5 Preloaded Suture Anchor with Needles (Durabraid) TwinFix AB 5 Suture Anchor w/Two 38” UltraBraid Sutures (#2) & 5 Threaded Dilator w/Inserter Guide BIORAPTOR 2.9mm Suture Anchor with two 38” ULTRABRAID Sutures (#2) TWINFIX™ Ultra HA 5.5mm Suture Anchor w/TWO (#2) ULTRABRAID™ Sutures (blue and blue co-braid) and Needles TwinFix AB 5 Suture Anchor w/Two 38” DuraBraid Sutures (USP #2) TwinFix AB 5 Preloaded Suture Anchor with UltraBraid Suture and Needles TWINFIX™ Ultra HA 4.5mm Suture Anchor w/two #2 ULTRABRAID™ sutures (white/cobraid blue) TWINFIX™ Ultra HA 6.5mm Suture Anchor w/TWO (#2) ULTRABRAID™ Sutures (blue and blue co-braid) and Needles RAPTORMITE 3.7 AB with Needles and Two #0 ULTRABRAID, White and Cobraid Blue OSTEORAPTOR Curved 2.3 Suture Anchor w/ONE 38” ULTRABRAID (#2) Suture (Cobraid Black) (Shoulder) TwinFix AB 6.5 Suture Anchor w/Two 38” DuraBraid Sutures (USP #2) & 5 Threaded Dilator TWINFIX™ Ultra HA 6.5mm Suture Anchor w/three #2 ULTRABRAID™ sutures TWINFIX AB 6.5 SUTR ANCHR W/2 38 ULTRA TWINFIX™ Ultra HA 5.5mm Suture Anchor w/three #2 ULTRABRAID™ sutures TWNFX 6.5AB PRLD STR ANCHR W/NEEDLES OSTEORAPTOR™ 2.9 Suture Anchor w/2 ULTRABRAID™ (#2) Suture (1 white , 1 cobraid black) OSTEORAPTOR™ 2.9 Suture Anchor w/2 ULTRABRAID™ (#2) Suture (1 white, 1 cobraid blue) TWINFIX AB 6.5 SUTR ANCR W/2 DURABRAID RAPTORMITE 3.7 AB W/NDL 20 ULTRABRAID TwinFix AB 5 Preloaded Suture Anchor with Needles and Threaded Dilator w/Durabraid OSTEORAPTOR CURVED 2.3 PLLA/HA SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLUE ULTRA FAST-FIX AB ASSEMBLY - CURVED TWNFX 5AB STR ANCHR W/2NDLS THREAD TWINFIX ULTRA 4.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE TWINFIX™ Ultra HA 4.5mm Suture Anchor w/TWO (#2) ULTRABRAID™ Sutures (blue and blue co-braid) and Needles OSTEORAPTOR™ 2.3 Suture Anchor w/ULTRABRAID™ (#2) Suture, White TWINFIX™ Ultra HA 4.5mm Suture Anchor w/two #2 ULTRABRAID™ sutures (cobraid blue/cobraid black) OSTEORAPTOR 2.9 W/ 1 UB WHITE TWINFIX ULTRA 5.5 MM POLY L LACTIC ACID-HA SUTURE ANCHOR WITH TWO No.2 ULTRABRAID SUTURES BLUE, BLUE-COBRAID WITH NEEDLE HEALICOIL REGENESORB 4.75mm Suture Anchor with two ULTRABRAID (#2) sutures (blue/cobraid blue) TwinFix AB 5 Suture Anchor w/Two 38” DuraBraid Sutures (USP #2) & 5 Threaded Dilator w/Inserter Guide BIORAPTOR 2.9mm Suture Anchor with two 38” DURABRAID Sutures (USP#2) TWINFIX™ Ultra HA 6.5mm Suture Anchor w/two #2 ULTRABRAID™ sutures (white/cobraid blue) TWNFX AB 5STR ANCR 2 38 ULTR THR DILTR TWINFIX™ Ultra HA 5.5mm Suture Anchor w/two #2 ULTRABRAID™ sutures (cobraid blue/cobraid black) OSTEORAPTOR™ 2.3 Suture Anchor w/ULTRABRAID™ (#2) Suture (cobraid blue) TWINFIX ULTRA 6.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE TWINFIX ULTRA 6.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES WHITE, COBRAID-BLUE STERILE TwinFix AB 6.5 Suture Anchor w/Two UltraBraid Sutures (#2) TWNFX 6.5AB PRLD STR ANCHR W/TWO NDLS HEALICOIL REGENESORB 5.5mm Suture Anchor with three ULTRABRAID (#2) sutures (blue/cobraid blue /cobraid black) BIORAPTOR 2.9mm Suture Anchor with one 38” ULTRABRAID Co-Braid Suture (#2) OSTEORAPTOR 2.3 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 SUTURE COBRAID BLACK HEALICOIL REGENESORB 5.5mm Suture Anchor with two ULTRABRAID (#2) sutures (blue/cobraid blue) HEALICOIL RG 4.75MM W2 MT BL/CB WH OSTEORAPTOR 2.3 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 SUTURE COBRAID BLUE TWINFIX AB 5 SUTR ANCHR W/2 38 ULTRA OSTEORAPTOR 2.9 SUTURE ANCHOR WITH ONE ULTRABRAID No.2 SUTURE COBRAID BLUE OSTEORAPTOR 2.9 SUTURE ANCHOR WITH TWO ULTRABRAID No.2 SUTURE WHITE/COBRAID BLACK TwinFix AB 6.5 Suture Anchor w/Two 38” DuraBraid Sutures (USP #2) TWINFIX™ Ultra HA 6.5mm Suture Anchor w/two #2 ULTRABRAID™ sutures (cobraid blue/cobraid black) TwinFix AB 6.5 Preloaded Suture Anchor with UltraBraid Suture and Needles OSTEORAPTOR™ 2.3 Suture Anchor w/ULTRABRAID™ (#2) Suture (cobraid black) TWINFIX™ Ultra HA 5.5mm Suture Anchor w/two #2 ULTRABRAID™ sutures (white/cobraid blue) ULTRA FAST-FIX AB Straight Needle Delivery System TwinFix AB 5 Preloaded Suture Anchor with UltraBraid Suture and Needles w/Threaded Dilator OSTEORAPTOR Curved 2.3 Suture Anchor w/ONE 38” ULTRABRAID (#2) Suture (Cobraid Blue) (Shoulder) HEALICOIL RG 5.5MM W2 MT BL/CB WH OSTEORAPTOR 2.9 SUTURE ANCHOR WITH TWO ULTRABRAID No.2 SUTURE WHITE/COBRAID BLUE HEALICOIL RG 4.75MM W3 MT BL/CB WH/CB BL OSTEORAPTOR CURVED 2.3 PLLA/HA SUTURE ANCHOR, WITH ONE ULTRABRAID No.2 SUTURE COBRAID-BLACK TWINFIX 5AB STR ANCHR W/2STR &NDLS ULTRA FAST-FIX AB ASSEMBLY - REVERSE CURVED TWINFIX ULTRA 6.5 MM HIDROXYAPATITE ANCHOR WITH THREE No.2 SUTURES WHITE, COBRAID-BLUE, COBRAID-BLACK STERILE HEALICOIL RG 5.5MM W3 MT BL/CB WH/CB BL

    Establishment Types

    Manufacture Medical Device