The following data is part of a premarket notification filed by Exactech Inc. with the FDA for Exactech Equinoxe Small Reverse Shoulder System.
| Device ID | K180632 |
| 510k Number | K180632 |
| Device Name: | Exactech Equinoxe Small Reverse Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Exactech Inc. 2320 NW 66th Court Gainesville, FL 32653 |
| Contact | Zach Sharrah |
| Correspondent | Zach Sharrah 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-12 |
| Decision Date | 2018-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862606808 | K180632 | 000 |