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

Clearance record K131298

EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM · Exactech, Inc. · decided 2013-11-26 (SESE)

FDA 510(k) database ↗Summary PDF ↗

Devices

BrandModelCompanyProduct codesPrimary DI
Equinoxe313-10-41Exactech, Inc.HSD10885862252272
Equinoxe313-10-50Exactech, Inc.HSD10885862662484
Equinoxe313-10-44Exactech, Inc.HSD10885862252289
Equinoxe313-05-02Exactech, Inc.HSD10885862252197
Equinoxe312-01-38Exactech, Inc.HSD10885862248503
Equinoxe313-25-44Exactech, Inc.HSD10885862648273
Equinoxe313-10-38Exactech, Inc.HSD10885862252265
Equinoxe313-25-38Exactech, Inc.HSD10885862252357
Equinoxe312-01-47Exactech, Inc.HSD10885862248534
Equinoxe312-01-41Exactech, Inc.HSD10885862248510
Equinoxe313-10-53Exactech, Inc.HSD10885862662491
Equinoxe313-07-02Exactech, Inc.HSD10885862648136
Equinoxe313-25-41Exactech, Inc.HSD10885862252364
Equinoxe313-05-02Exactech, Inc.HSD10885862648105
Equinoxe313-25-44Exactech, Inc.HSD10885862252371
Equinoxe313-07-02Exactech, Inc.HSD10885862252227
Equinoxe313-07-07Exactech, Inc.HSD10885862252241
Equinoxe313-05-10Exactech, Inc.HSD10885862252203
Equinoxe313-10-41Exactech, Inc.HSD10885862662453
Equinoxe313-25-50Exactech, Inc.HSD10885862252395
Equinoxe313-25-00Exactech, Inc.HSD10885862252340
Equinoxe313-25-38Exactech, Inc.HSD10885862648259
Equinoxe313-10-53Exactech, Inc.HSD10885862252319
Equinoxe313-07-07Exactech, Inc.HSD10885862648167
Equinoxe313-05-01Exactech, Inc.HSD10885862648099