FDA Registration
Active
🇨🇭 Switzerland
11MM DILATOR
Reg #: 9613369
·
FEI: 3002807893
·
Expires 2025
Products
1
Proprietary Names
244
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SMITH & NEPHEW ORTHOPAEDICS AG
- Registration Number
- 9613369
- FEI Number
- 3002807893
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- SCHACHENALLEE 29, DAMMWEG 39
- City
- AARAU Aargau
- Country
- CH
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 |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-10-05 |
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
Manufacture Medical Device