FDA Registration
Active
🇨🇷 Costa Rica
TWINFIX ULTRA 5.5 MM HIDROXYAPATITE ANCHOR WITH TWO No.2 SUTURES COBRAID-BLUE, COBRAID-BLACK STERILE
Reg #: 3012358417
·
FEI: 3012358417
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Expires 2025
Products
5
Proprietary Names
83
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Arthrocare Corporation
- Registration Number
- 3012358417
- FEI Number
- 3012358417
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- B32.1, St2, Zona Franca Coyol
- City
- Coyol Alajuela
- Country
- CR
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
US Agent
- Business Name
- Smith & Nephew, Inc.
- Contact Name
- Lisa Ewing
- Address
- 2875 Railroad St
- City
- Pittsburgh
- State
- PA
- ZIP
- 15222
- Country
- US
- [email protected]
- Phone
- 412 4199765
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Biodegradable, Soft Tissue | MAI | Class 2 | Orthopedic | No | 2015-08-10 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2015-08-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-08-10 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2015-08-10 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2015-08-10 |
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