The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap.
| Device ID | K182536 |
| 510k Number | K182536 |
| Device Name: | Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap |
| 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 | 2018-09-14 |
| Decision Date | 2018-10-12 |
| Summary: | summary |