FDA.report

Stryker Macroom

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30083378083008337808Stryker Macroom1N2026-01-01Hartnetts Cross Macroom Co Cork Munster IE P12 XA50

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2922901815012218K994393AEQUALIS UNIVERSAL SHOULDER GLENOIDKWS2000-06-22
2922902025940209K994392AEQUALIS SHOULDER FRACTURE SYSTEMKWS2000-03-10
2922901381099311K952928AEQUALIS SHOULDER SYSTEM FOR TOTAL & HEMISHOULDER APPLICATIONSKWS1995-09-27
2922901642955328K203228DART-FIRE EDGE Cannulated Screw SystemHWC2021-05-11
2922901740312837K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed GlenoidPHX2016-11-15
2922901023280719K160975Aequalis PerFORM+ Shoulder SystemKWS2016-06-10
2922901264632267K131231AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROTHESISPHX2013-10-16
2922901218488497K113413ASCEND SHOULDER SYSTEMKWS2012-03-09
2922901653768571K061439AEQUALIS REVERSED PROSTHESISPHX2006-07-20
2922901460999586K060209AEQUALIS SHOULDER FRACTURE SYSTEM & AEQUALIS SHOULDER SYSTEMKWS2006-03-02
2922901261836076K050316AEQUALIS REVERSED SHOULDER PROSTHESISPHX2005-03-16
2922901393537684K041873AEQUALIS REVERSED SHOULDER PROSTHESISPHX2004-08-25
2922901770790956K041339AEQUALIS SHOULDER SYSTEMKWS2004-06-17
2922901020390595
2922901060462491
2922901108402969
2922901158602318
2922901194616089
2922901200392552
2922901253003347
2922901391668790
2922901402134835
2922901436574305
2922901450090262
2922901473542730
2922901503847797
2922901605502150
2922901615666766
2922901640230755
2922901654360205
2922901696456786
2922901734719630
2922901748885292
2922901834747167
2922901844583934
2922901853771301
2922901922160208
2922901943417516
2922901981062186

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
KWS72016-06-10
PHX52016-11-15
HWC12021-05-11