FDA.reportPublic FDA data

SHOULDER INNOVATIONS, Inc

Matched from indexed company URL: 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

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
B1130S1GK000020Shoulder Innovations Humeral Short Stem System - Shoulder Innovations - TSA - Humeral Short Stem System. Instrument: K-Wire Guide 2.4 mm616-294-1026xxx@xx.xx
B1130S1GK000030Shoulder Innovations InSet 70 Humeral Stem - Shoulder Innovations - InSet 70 Humeral Stem - Instrument: K-Wire, 2.4mm x 90mm616-294-1026info@shoulderinnovations.com
B1130S1GK00020SHOULDER INNOVATIONS TSA SYSTEM - K WIRE616 294-1026natt@shoulderinnovations.com

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

PMN#

GUDID#

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