FDA Registration Active 🇨🇷 Costa Rica

11MM DILATOR

Reg #: 3012358417 · FEI: 3012358417 · Expires 2025
Products
1
Proprietary Names
244
Establishment Types
3
Classifications
1

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

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
Phone
412 4199765

Products

Device Name Product Code
Orthopedic Manual Surgical Instrument LXH

Proprietary Names

11MM DILATOR 12MM DILATOR 8.5MM DILATOR Rotation Tendon Marker LOOP TIP GUIDEWIRE 8MM DILATOR Lobster Claw Suture Retriever ACL Open Curette N8TIVE ACL Graft Sizing Block Graft, Suture Clamp N8TIVE ACL Femoral Drill Guide Trocar Manta Swordfish Hammerhead Rotary Scissor Graft Assist, Board Femoral Locator Chondral Pick Toothless Shark Atraumatic Grasper Tunnel Notcher Graft, Tissue Clamp Titan Removal Tool Capture Sleeve Transverse Arm Graft, Base Lock Wissinger Rod Suture Clamp Tension meter N8TIVE ACL Tibial Sheath Inserter Universal Rachet Handle Point to Elbow, ACL Arm N8TIVE ACL Tibial Button Impactor Hammerhead Rotary Punch Meniscal Lift Marlin Long Probe Jaws Retro Junior Grasper Guidewire Aimer A-Tech Controlled Flexion Guidewire Bone Tap MegaMouth Grasper Probe Titan Bone Punch Crochet Hook Depth Probe Slotted Tendon Harvester Jaws Tigar Shark Grasper Suture Hook N8TIVE ACL Tibial Dilator A-Tech Femoral Locator Handle N8TIVE ACL Tendon Harvester Bilok ST Graft Expander Jaws Great White Grasper Cannulated Switching Stick N8TIVE ACL Tunnel Rasp Elevator Rasp N8TIVE ACL Curette Multi-Sizing Block Slap Hammer ACL Bullet Radial Clamp N8TIVE ACL Disposables Kit ACL Disposables Guidewire Kit Passing Pin Puller Cannula Driver Ankle Distractor Strap Ankle Distractor Tibial Tunnel Plug Small Joint Probe Point to Point, ACL Arm Transverse Bullet Cuff Elevator ACL Disposables Kit Piranha Arthroscopic Rongeur Closed Tendon Harvester ACL Closed Curette Removal Tool Driver; MTO DRIVER 3.5MM 1.5MM CANN W/HUD ADAP; MTO DRIVER BIORCI W/HUDSON ADAPTOR Piranha Junior Tapered Tap Metal Screw Driver Shaft Jaws Retro Toothed Grasper Blunt Nose Junior Femoral Aimer REFLECTION Tunnel Expander Graft Bar Holder Beluga Retro Meniscal Rasp N8TIVE ACL Depth Gage Clearcut Suture Cutter ACL Tunnel Rasp Single Hole Knot Pusher Graft Board Hook Adaptor JOURNEY PERI-LOC TRIGEN EMPERION Rotation Medical Mini-Open Instrument Kit Inserter Tip Rotation Medical Arthroscopic Instrument Kit TANDEM LARGE QWIX Integra Surgical Instrument Set Integra Surgical Instrument - Driver GENESIS Accu-pass suture shuttle, Big Curve PANTA Passing pin Spade tip 3mm, 72202814 Integra Surgical Instrument - Planer Integra Glenoid Holder QWIX Biosure 1.2mm x 18", 72201201 Integra Pin Puller Round Oval Sizing Guide Awl tapered 3.8mm Guidewire 2.4mm Drill Tip, guide wire, 12", 7207221 Accu-Pass Suture Shuttle, Monoflement Size No. 1, Single Pack, Sterile - 72201361 TIBIAXYS Accu-pass suture shuttle left 45 degree, 7210423 Biosure Guide Wire, 1.2mm x 9 inch, Box of 5, Sterile Guidewire 1.5mm x 229mm Suretac 6mm Guidewire, 72202809 Beath pin 2.4mm, 72202815 Wire and pin pac (C) PCL Guidewire, 7207284 LABELS FOR RING MODULE Twinfix AB 5mm threaded dilator, 72200819 Wire and pin pac (B) guide wire 2mm Cannuflex 9" Blunt Guidewire, 72202807 Twinfix AB 6.5mm threaded dilator, 72200820 Wire and pin pac, 7207738 Guide wire 2mm, 15", 7207222 Accu-pass suture shuttle right 45 degree Pliers, Compaction, 9MM Accu-pass suture shuttle, straight, 7210426 1.5mm Guidewire, 12", 72202189 Endobutton Pin Passing 2.4mm Trocar Accu-pass suture shuttle 45 degree up, 7210425 Guidewire, Nitinol 1.2mm x 45cm Accu-pass suture shuttle 70 degree, Upbend, 72200419 Awl straight 3.8mm, 72202986 Accu-pass suture shuttle, crescent, 7210427 Arthroscopic needle, 72202825 Awl, tap, driver, dilator Drill for Q-FIX with Needles SWISS RAIL CLAMP (LATERAL DSTRCTR SYS) US SUPINE RAIL CLAMPS 2, 0.375 INCH X 1.125 INCH 1 CM X 2.9 CM RCI 7.5 MM TIBIAL STEPPED ROUTER GUIDE WR 1.2MM X 12 BOX OF 5 STERILE 1.5 MM TENDON DRILL PIN RCI 8 MM TIBIAL STEPPED ROUTER SUTURE NEEDLE SHUTTLE STERILE WELL LEG HOLDER WITH LEATHER BOOT 9MM TENDON FORK GUIDEWIRE SURETAC 6 MM 39 X 15 RCI 8.5 MM FEMORAL STEPPED ROUTER MAVERICK MINI STITCHER BIORAPTOR KNOTLESS INLINE DRILL GUIDE, SPIKE TIP BI-GRIP PIN PULLER GUIDEWIRE CANNFLEX 9 BLUNT TIP 4 MM ANTI-IMINGEMENT DEVICE, USED WITH 7 MM AND 8 MM GRAFTS 5 MM ANTI-IMPINGEMENT DEVICE, USED WITH 9 MM AND 10 MM GRAFTS 4.5 MM DILATOR 9MM DILATOR GUIDE WIRE BEATH PIN 2.4 MM STERILE KNEE HOLDER SCREW GUIDE WIRE, 2 MM X 12 INCH 30CM, BLUNT TIP, STERILE 6 PER PACKAGE MTO AWL-DILATOR TF ULTRA 4.5 CORTICAL LARGE INSERTER DSP PERINEAL POST DENYER SUPINE RAIL CLAMPS 2 ARTHROPIERCE XL STRAIGHT TROCAR-TIP PASSING PIN, 2.4 MM X 17 INCH, STERILE 6MM DILATOR 2.7 MM DILATOR TWINFIX AB 5 THREADED DILATOR OPEN CURETTE 4.5MM XL 8MM TENDON FORK TWINFIX AB 6.5 THREADED DILATOR MTO GUIDE WIRE AC JOINT 2.4 MM 3.5 MM DILATOR 8.5 MM DILATOR DIRECTOR PCL ELEVATOR WITH WIRE CATCHER AWL STRAIGHT 3.8MM DISPOSABLE GD WIRE NITINOL 1.2 X 45CM RCI 7 MM FEMORAL STEPPED ROUTER 10MM DILATOR 9.5MM DILATOR RCI 7 MM TIBIAL STEPPED ROUTER MTO,SCRW DRVR,LOCKING, 2.5MM HEX, CANN KNOT PUSHER XL ACCU-PASS SUTURE SHUTTLE, MONOFILAMENT SIZE No.1, SINGLE PACK, STERILE RCI 8.5 MM TIBIAL STEPPED ROUTER 8MM BICEPTOR TAP SCREW GUIDE WIRE, 1.5 MM X 12 INCH 30 CM, BLUNT TIP, STERILE RCI 7.5 MM FEMORAL STEPPED ROUTER SWISS RAIL CLAMP (SUPINE DSTRCTR SYS) PASSING PIN, 3 MM, SPADE TIP DENYER RAIL CLAMP (LATERL DSTRCTR SYS) 7MM DILATOR MTO GUIDEWIRE THREADED 1.5MM X 45CM 2.4 MM X 12 INCH DRILL-TIP GUIDE WIRE MTO AWL-DIL TF ULTRA 5.5/6.5 CORTICAL LOCKING WRENCH GUIDE WIRE 1.2MM X18 BX OF 5 STER. US LATERAL RAIL CLAMP 2 rail clamp, passing pin TruKor Gauge 6.5MM DILATOR Extremities Guide, Universal ACCUPASS STR SHUTL MONOFIL -SEE72201361 LARGE TENDON STRIPPER, CLOSED, 7.4 MM I.D. X 13.5 INCH WORKING LENGTH REPLACEMENT LEATHER BOOT 1 STYLET FOR STITCHER 7MM TENDON FORK MTO TWINFIX ULTRA 5.5 FOR 5.5 CANNULA RCI 6.5 MM TIBIAL STEPPED ROUTER GUIDE WIRE PCL 2.4MM X10 OPEN CURETTE 6MM REVERSE CUT XL EUR/UK LATERAL RAIL CLAMPS 2 0.394 INCH X 0.984 INCH ACCU-PASS STR SHTL BIG C STERILE BOX 1 TWINFIX 3.8 MM STRAIGHT AWL, REUSABLE TENDON STRIPPER, SLOTTED, 5 MM I.D. X 12 INCH WORKING LENGTH UNIVERSAL HIP DISTRACTOR WITH LEATHER BOOT 7MM BICEPTOR TAP BOARD, PATIENT TRANSFER MANUAL INSTRUMENT TRAY EUR/UK RAIL CLAMP (LATERL DSTRCTR SYS) SUPINE TABLE ATTACHMENT PAD PLIERS, COMPACTION, 9mm ARTHROSCOPIC NEEDLE STERILE 7.5MM DILATOR RCI 8 MM FEMORAL STEPPED ROUTER AWL-DILATOR AB 5MM TWINFIX TENDON STRIPPER CLOSED RCI 6.5 MM FEMORAL STEPPED ROUTER CANNU-FLEX SCREW GUIDE WIRE, 2 MM X 15 INCH 38 CM, BLUNT TIP, STERILE HAMMER SLAP DILATOR SYSTEM Tendon Stabilizing Guide GUIDE WIRE 1.2MM X 9 BOX OF 5 STERILE WHIPKNOT SOFT TISSUE CINCH 5 SUTURE SMALL INSERTER DSP 6.5 MM DILATOR ACCU-PASS SUTURE SHUTTLE 70 DEGREE

Establishment Types

Remanufacture Medical Device Repack or Relabel Medical Device Manufacture Medical Device