FDA.reportPublic FDA data

b-ONE Ortho Corp.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30425082543042508254b-ONE Ortho Corp.1Y2026-01-01159 Dwight Pl Fairfield NJ US 07004

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3462051402405631K253357b-ONE® Bipolar HeadKWY2026-04-13
3462051219564302K240528b-ONE® Total Hip SystemLZO2024-11-15
3462051969580502K222431b-ONER MOBIO Total Knee SystemJWH2022-10-06
3462051667441525K213673b-ONE MOBIO Total Knee SystemJWH2022-01-21
3462052056499470K210483MOBIO Total Knee SystemJWH2021-04-21
3462051007727253K202768KOSMO Femoral StemLZO2021-04-01
3462051959815932K202429Mobio Total Knee SystemJWH2020-10-23
3462051827677341K183025MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar ComponentJWH2019-01-28
3462051964195446K182705Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System CupsLZO2019-02-14
3462051766541431K180446b-ONE Total Knee SystemJWH2018-10-12
3462051066316163K173380b-ONE® Total Hip SystemLZO2018-08-30
3462051008671229
3462051088236822
3462051147306631
3462051277981507
3462051550998243
3462051561811394
3462051604755259
3462051664622438
3462051672580004
3462051715266937
3462051717053521
3462051835889517
3462051901544582
3462052003499480
3462052030434793
3462052038953734
3462052071999118

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH62022-10-06
LZO42024-11-15
KWY12026-04-13

PMN#