FDA.reportPublic FDA data

Andrew Hewes

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30125230633012523063Andrew Hewes1N2026-01-0113465 Midway Rd Ste 310 Dallas TX US 75244

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2111851217074175K260037implantcast Packaging System UpdateLZO2026-03-30
2111851412638475K252451EPORE® XO cup systemOQI2026-04-24
2111851793679388K252401implaFit® short stemsLZO2026-03-12
2111851316883727K241944AGILON® XO Shoulder Replacement SystemKWT2025-03-10
2111851847905729K240834EcoFit® short stem cementless cpTiLZO2024-06-03
2111851342131162K240391MUTARS® femoral stem cemented 160 mm and 200 mmLZO2024-10-24
2111851863000819K234044ACS® LD FB Knee SystemJWH2024-09-06
2111851220930586K232371Actinia® hip stemsLZO2023-10-19
2111851052405957K231657AGILON® XO Shoulder Replacement SystemKWT2024-02-16
2111851481088975K223103BethaLoc® stem cementless HALZO2023-06-20
2111851473046452K222482AGILON XO Shoulder SystemKWT2022-09-28
2111851651233956K210678implaFit® hip stemsLZO2022-08-17
2111851883364566K203420EcoFit® Hip SystemLZO2021-02-03
2111851451991036K203341ACS LD Uni FB Knee SystemHSX2021-01-08
2111851931056209K200045MUTARS Cemented Femoral StemsMEH2020-10-16
2111852038903072K191569Implantcast ic-Bipolar Head SystemKWY2019-08-28
2111851659166243K191433AGILON® XO Shoulder Replacement SystemHSD2020-11-12
2111851891933079K181778MUTARS Proximal Femur Replacement SystemMEH2019-03-25
2111851400980653K180263EcoFit Vit E Acetabular SystemLZO2018-07-20
2111851564535220K163577Ecofit® Hip SystemLZO2017-09-25
2111851015126592
2111851045436244
2111851150419717
2111851171076719
2111851280610211
2111851296803684
2111851374299493
2111851440793177
2111851588078487
2111851599014263
2111851687663595
2111851731978746
2111851786539029
2111851912941992

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LZO102026-03-30
KWT32025-03-10
MEH22020-10-16
OQI12026-04-24
JWH12024-09-06
HSX12021-01-08
HSD12020-11-12
KWY12019-08-28