FDA.reportPublic FDA data

SMITH & NEPHEW ORTHOPAEDICS LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30059759293005975929SMITH & NEPHEW ORTHOPAEDICS LTD.1N2020-04-25AURORA HOUSE, SPA PARK HARRISON WAY LEAMINGTON SPA Warwickshire GB CV31 3HL

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
281651345256376P150030R3 DELTA CERAMIC HIP SYSTEMMRA2016-10-17
281651810503267P040033BIRMINGHAM HIP RESURFACING (BHR) SYSTEMNXT2006-05-09
281651076186527K171934Birmingham Hip (BH) Dual Mobility InsertLPH2017-11-30
281651731612594K092386R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERSMBL2009-11-03
281651416880922K070756SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEMMBL2007-06-06
281651376303751
281651612799697
281651768866068
281651933153809

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
MBL22009-11-03
LPH12017-11-30
MRA12016-10-17
NXT12006-05-09