FDA Registration Active 🇺🇸 United States

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

Reg #: 3006524618 · FEI: 3010813691 · Expires 2025
Products
1
Proprietary Names
86
Establishment Types
1
Classifications
1

Registration Details

Registration Name
ArthroCare Corporation
Registration Number
3006524618
FEI Number
3010813691
Status
Active
Expiry Year
2025
Initial Importer
No
Address
7000 W William Cannon Dr
City
Austin
State
TX
ZIP
78735
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

Manufacture Medical Device