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Recognized a 510(k)/PMA number — showing its clearance record and devices.

Clearance record K192206

32mm Glenosphere and Humeral Cup · Fx Shoulder USA, Inc. · decided 2019-10-08 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Humeral Cup Standard312-0703FX SOLUTIONSHSD KWT PHX03701037310588
32mm Glenosphere and Humeral Cup102-0809FX SOLUTIONSHSD KWT PHX03701037309377
Humelock Reversed System105-3210FX SOLUTIONSPHX03701037309476
Humelock Reversed System105-3211FX SOLUTIONSPHX03701037309483
32mm Glenosphere and Humeral Cup102-0803FX SOLUTIONSHSD KWT PHX03701037309353
32mm Glenosphere and Humeral Cup102-0806FX SOLUTIONSHSD KWT PHX03701037309360
Humeral Cup Standard312-0706FX SOLUTIONSHSD KWT PHX03701037310595
Humeral Cup Standard312-0709FX SOLUTIONSHSD KWT PHX03701037310601