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

Clearance record K150458

Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere · Exactech, Inc. · decided 2015-05-14 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Equinoxe320-02-46Exactech, Inc.PHX10885862286871
EquinoxeSPI-038814Exactech, Inc.KWS KWT PHX10885862596079
EquinoxeSPI-037397Exactech, Inc.KWS KWT PHX10885862594167