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)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Equinoxe | 313-10-41 | Exactech, Inc. | HSD | 10885862252272 |
| Equinoxe | 313-10-50 | Exactech, Inc. | HSD | 10885862662484 |
| Equinoxe | 313-10-44 | Exactech, Inc. | HSD | 10885862252289 |
| Equinoxe | 313-05-02 | Exactech, Inc. | HSD | 10885862252197 |
| Equinoxe | 312-01-38 | Exactech, Inc. | HSD | 10885862248503 |
| Equinoxe | 313-25-44 | Exactech, Inc. | HSD | 10885862648273 |
| Equinoxe | 313-10-38 | Exactech, Inc. | HSD | 10885862252265 |
| Equinoxe | 313-25-38 | Exactech, Inc. | HSD | 10885862252357 |
| Equinoxe | 312-01-47 | Exactech, Inc. | HSD | 10885862248534 |
| Equinoxe | 312-01-41 | Exactech, Inc. | HSD | 10885862248510 |
| Equinoxe | 313-10-53 | Exactech, Inc. | HSD | 10885862662491 |
| Equinoxe | 313-07-02 | Exactech, Inc. | HSD | 10885862648136 |
| Equinoxe | 313-25-41 | Exactech, Inc. | HSD | 10885862252364 |
| Equinoxe | 313-05-02 | Exactech, Inc. | HSD | 10885862648105 |
| Equinoxe | 313-25-44 | Exactech, Inc. | HSD | 10885862252371 |
| Equinoxe | 313-07-02 | Exactech, Inc. | HSD | 10885862252227 |
| Equinoxe | 313-07-07 | Exactech, Inc. | HSD | 10885862252241 |
| Equinoxe | 313-05-10 | Exactech, Inc. | HSD | 10885862252203 |
| Equinoxe | 313-10-41 | Exactech, Inc. | HSD | 10885862662453 |
| Equinoxe | 313-25-50 | Exactech, Inc. | HSD | 10885862252395 |
| Equinoxe | 313-25-00 | Exactech, Inc. | HSD | 10885862252340 |
| Equinoxe | 313-25-38 | Exactech, Inc. | HSD | 10885862648259 |
| Equinoxe | 313-10-53 | Exactech, Inc. | HSD | 10885862252319 |
| Equinoxe | 313-07-07 | Exactech, Inc. | HSD | 10885862648167 |
| Equinoxe | 313-05-01 | Exactech, Inc. | HSD | 10885862648099 |