FDA.reportPublic FDA data

SHOULDER INNOVATIONS, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30125446353012544635SHOULDER INNOVATIONS, Inc1N2026-01-011535 Steele Ave SW Suite B Grand Rapids MI US 49507

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1950371284114986K241817InSet Total Shoulder SystemKWT2025-02-11
1950371654572862K213615Shoulder Innovations Total Shoulder SystemPKC2022-03-11
1950371929402306K210533Inset Reverse Total Shoulder SystemPHX2021-08-20
1950371821231402K192365Shoulder Innovations Total Shoulder SystemKWT2019-11-29
1950371633789994K173824Humeral Short Stem SystemMBF2018-10-23
1950371171965895K111596TOTAL SHOULDER SYSTEMKWS2011-07-05
1950372003124803K110905TOTAL SHOULDER SYSTEMKWS2011-05-24
1950371725766457K102670TOTAL SHOULDER SYSTEMKWS2011-01-24

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KWS32011-07-05
KWT22025-02-11
PKC12022-03-11
PHX12021-08-20
MBF12018-10-23