FDA.reportPublic FDA data

SERF

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30086688013008668801SERF1N2027-01-0185 Avenue des Bruyeres DECINES CHARPIEU Rhone FR 69150
30086688013008668801SERF1N2020-04-2585 Avenue des Bruyeres Decines Rhone FR 69150

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3291111840618072K250989Stryker and Serf hip devicesLPH2025-07-25
3291111958139575K223745Novae® Dual Mobility System, Hype® Hip SystemLZO2023-12-22
1327951555982759K181744BI-MENTUM dual mobility systemLZO2018-12-11
3291111702655825K181744BI-MENTUM dual mobility systemLZO2018-12-11
3291111165743245K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupLZO2015-01-15
1327951798761287K142675CI../..X liner for NOVAE Dual Mobility Acetabular CupLZO2015-01-15
3291111255361309K111572NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODELLZO2011-08-29
1327951339452574K111572NOVAE SUNFIT TH DUAL MOBILITY ACETABULAR CUP MODEL SUNFIT TH (METAL-BACK), NOVAE E TH DUAL MOBILITY ACETABULAR CUP MODELLZO2011-08-29
1327951646351575
1327951686681736
1327951693184200
1327951919168955
1327952068274836
3291111035153527
3291111154504975
3291111406486892
3291111569771303
3291111860049516

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZO72023-12-22
LPH12025-07-25

PMN#