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

Clearance record K202098

GLOBAL UNITE™ Platform Shoulder System · Depuy Ireland UC · decided 2020-11-25 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
GLOBAL GLOBAL UNITE1100-14-800DEPUY (IRELAND)HSD KWS PHX10603295523376
GLOBAL GLOBAL UNITE1100-16-800DEPUY (IRELAND)HSD KWS PHX10603295523383
GLOBAL GLOBAL UNITE1100-12-800DEPUY (IRELAND)HSD KWS PHX10603295523369
GLOBAL GLOBAL UNITE1100-10-800DEPUY (IRELAND)HSD KWS PHX10603295523352