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

Clearance record K233482

Equinoxe® Central Screw Baseplate System · Exactech, Inc. · decided 2024-07-18 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Equinoxe®320-55-07Exactech, Inc.KWT PHX10885862625656
Equinoxe®321-19-19Exactech, Inc.KWT PHX10885862631602
Equinoxe®320-55-01Exactech, Inc.KWT PHX10885862625618
Equinoxe®321-52-67Exactech, Inc.KWT PHX10885862631626
Equinoxe®320-55-03Exactech, Inc.KWT PHX10885862625632
Equinoxe®321-19-34Exactech, Inc.KWT PHX10885862631589
Equinoxe®321-52-66Exactech, Inc.KWT PHX10885862631619
Equinoxe®320-55-04Exactech, Inc.KWT PHX10885862625649
CSB321-52-68Exactech, Inc.KWT PHX10885862657046
Equinoxe®320-55-98Exactech, Inc.KWT PHX10885862630384
Equinoxe®320-55-08Exactech, Inc.KWT PHX10885862625663
Equinoxe®320-55-02Exactech, Inc.KWT PHX10885862625625
CSB321-52-69Exactech, Inc.KWT PHX10885862657053
Equinoxe®321-19-15Exactech, Inc.KWT PHX10885862631633
Equinoxe®321-19-35Exactech, Inc.KWT PHX10885862631565
Equinoxe®321-19-20Exactech, Inc.KWT PHX10885862631640
CSB321-19-16Exactech, Inc.KWT PHX10885862657237
Equinoxe®321-07-15Exactech, Inc.KWT PHX10885862631596
Equinoxe®321-52-11Exactech, Inc.KWT PHX10885862631657