The following data is part of a premarket notification filed by Exactech, Inc with the FDA for Exactech Equinoxe Humeral Augmented Trays.
| Device ID | K191561 |
| 510k Number | K191561 |
| Device Name: | Exactech Equinoxe Humeral Augmented Trays |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Exactech, Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Contact | Shing Jen Tai |
| Correspondent | Shing Jen Tai Exactech, Inc 2320 NW 66th Court Gainesville, FL 32653 |
| Product Code | PHX |
| Subsequent Product Code | KWS |
| Subsequent Product Code | KWT |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-13 |
| Decision Date | 2019-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862567628 | K191561 | 000 |
| 10885862567796 | K191561 | 000 |
| 10885862567789 | K191561 | 000 |
| 10885862567772 | K191561 | 000 |
| 10885862567765 | K191561 | 000 |
| 10885862567758 | K191561 | 000 |
| 10885862567741 | K191561 | 000 |
| 10885862567734 | K191561 | 000 |
| 10885862567727 | K191561 | 000 |
| 10885862567710 | K191561 | 000 |
| 10885862567703 | K191561 | 000 |
| 10885862567697 | K191561 | 000 |
| 10885862567680 | K191561 | 000 |
| 10885862567802 | K191561 | 000 |
| 10885862567635 | K191561 | 000 |
| 10885862567642 | K191561 | 000 |
| 10885862567611 | K191561 | 000 |
| 10885862541284 | K191561 | 000 |
| 10885862541277 | K191561 | 000 |
| 10885862541260 | K191561 | 000 |
| 10885862541253 | K191561 | 000 |
| 10885862541246 | K191561 | 000 |
| 10885862541239 | K191561 | 000 |
| 10885862617743 | K191561 | 000 |
| 10885862617736 | K191561 | 000 |
| 10885862576095 | K191561 | 000 |
| 10885862576088 | K191561 | 000 |
| 10885862567659 | K191561 | 000 |
| 10885862567673 | K191561 | 000 |