Smith Nephew Orthopaedics L T D

FDA Filings

This page includes the latest FDA filings for Smith Nephew Orthopaedics L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Smith Nephew Orthopaedics L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• KEVIN - WALLS, RAC

FDA Registration(s)

• Registration Number: 3005975929
• FEI Number: 3005975929
• Name: SMITH & NEPHEW ORTHOPAEDICS LTD.
• Owner & Operator: Smith & Nephew, Inc.
• Contact Address: 7135 Goodlett Farms Parkway ; Cordova TN 38016 US
• Official Correspondent:
  • Beth Zis
  • x-978-7491260-x
• US Agent:
  • Jason Sells
  • SMITH & NEPHEW, INC.
  • 901 3995520
  • jason.sells@smith-nephew.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: AURORA HOUSE, SPA PARK HARRISON WAY; LEAMINGTON SPA Warwickshire, CV31 3HL GB
• Establishment Type:
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
PMN K171934 | LPH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	BIRMINGHAM HIP Dual Mobility Insert	2017-12-05
PMN K171934 | KWY SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	BIRMINGHAM HIP Dual Mobility Insert	2017-12-05
PMN K171934 | JDI SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	BIRMINGHAM HIP Dual Mobility Insert	2017-12-05
PMN P150030 | MRA SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	R3	2016-11-02
PMN P150030 | MRA SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	BIOLOX	2016-11-02
PMN K092386 | MBL SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	R3	2013-01-11
PMN K070756 | MBL SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	R3	2008-02-09
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	rail clamp, passing pin	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Wissinger Rod	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Universal Rachet Handle	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Tunnel Notcher	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Tunnel Expander	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Transverse Bullet	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Transverse Arm	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Toothless Shark Atraumatic Grasper	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Titan Removal Tool Capture Sleeve	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Titan Bone Punch	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Tibial Tunnel Plug	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Tapered Tap	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	TRIGEN	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	TANDEM	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Swordfish	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Suture Hook	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Suture Clamp Tension meter	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Small Joint Probe	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Slotted Tendon Harvester	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Slap Hammer	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Single Hole Knot Pusher	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Rotation Medical Mini-Open Instrument Kit	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Rotation Medical Arthroscopic Instrument Kit	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Removal Tool Driver	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Radial Clamp	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	REFLECTION	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Probe	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Point to Point, ACL Arm	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Point to Elbow, ACL Arm	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Piranha Junior	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Piranha Arthroscopic Rongeur	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Passing Pin Puller	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	PERI-LOC	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Tunnel Rasp	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Tibial Sheath Inserter	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Tibial Dilator	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Tibial Button Impactor	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Tendon Harvester	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Graft Sizing Block	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Femoral Drill Guide Trocar	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Disposables Kit	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Depth Gage	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	N8TIVE ACL Curette	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Multi-Sizing Block	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Metal Screw Driver Shaft	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Meniscal Rasp	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Meniscal Lift	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	MegaMouth Grasper	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Marlin	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Manta	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Long Probe	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Lobster Claw Suture Retriever	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Jaws Tigar Shark Grasper	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Jaws Retro Toothed Grasper	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Jaws Retro Junior Grasper	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Jaws Great White Grasper	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	JOURNEY	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Inserter Tip	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Hammerhead Rotary Scissor	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Hammerhead Rotary Punch	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Guidewire Aimer	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Graft, Tissue Clamp	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Graft, Suture Clamp	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Graft, Base Lock	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Graft Board Hook	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Graft Bar Holder	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Graft Assist, Board	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Femoral Locator	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Femoral Aimer	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Elevator Rasp	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	EMPERION	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Depth Probe	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Cuff Elevator	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Crochet Hook	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Closed Tendon Harvester	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Clearcut Suture Cutter	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Chondral Pick	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Cannulated Switching Stick	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Cannula Driver	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Bone Tap	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Blunt Nose Junior	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Bilok ST Graft Expander	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Beluga Retro	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Awl, tap, driver, dilator	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Ankle Distractor	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Ankle Distractor Strap	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Adaptor	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	ACL Tunnel Rasp	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	ACL Open Curette	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	ACL Disposables Kit	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	ACL Disposables Guidewire Kit	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	ACL Closed Curette	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	ACL Bullet	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	A-Tech Femoral Locator Handle	2006-10-05
LXH SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	A-Tech Controlled Flexion Guidewire	2006-10-05
HAB SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Saw, powered	2006-10-05
HAB SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	PowerMax Elite, hand control; Power moter drive	2006-10-05
HAB SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Blade, Sheath, Burr, Abrader, Incisor, Synovator, Acromionizer, Tubowhisker, Bonecutter, Acromioblaster, Notchblaster	2006-10-05
HAB SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	4.5 mm Synovator Platinum Curved Blade	2006-10-05
HAB SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	4.5 mm Incisor Plus Platinum Curved Blade	2006-10-05
HAB SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	4.0mm PLATINUM FLYER Blade, 72205292	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	VLP	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	VISIONAIRE	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Transverse Fixation Sterilization Tray	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Tip Pointer	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	TRIGEN	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	TRAY, SURGICAL	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	TANDEM	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	SPECTRON	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Registration Pointer	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	REFLECTION	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	PROFIX	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	PERI-LOC	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Large Sterilization Tray	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	LEGION	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	JET-X	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	INTERTAN	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Handheld Instrument Sterilization Tray, Small	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	HIP Tray	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	HEX-FIX	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Graftologer Tray	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	GENESIS	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	EMPERION	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	D-RAD	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Chondral Pick Sterilization Tray	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Bilok Instrument Sterilization Tray	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	Anatomic ACL Tray	2006-10-05
FSM SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	A-Tech ACL Sterilization Tray	2006-10-05
PMN P040033 | NXT SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	BIRMINGHAM HIP RESURFACING SYSTEM	2006-08-25
PMN P040033 | NXT SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	BHR	2006-08-25
FTY SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	TRIGEN	1978-02-27
FTY SMITH & NEPHEW ORTHOPAEDICS LTD. [Smith & Nephew, Inc.]	BHR	1978-02-27

Similar & Related FDA Registered Companies

• SMITH&NEPHEW ORTHOPAEDICS7135 Goodlett Farms Parkwaycordova, TN 38016 PMA NumberP040033 Supplement NumberS036 Date Received04/22/2022 Decision Date05/19/2022 Product Code NXT  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	KCYB0	SMITH & NEPHEW ORTHOPAEDICS LTD
CAGE Code	KCYB0	SMITH & NEPHEW ORTHOPAEDICS LTD