The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Eclipse Shoulder Prosthesis System.
| Device ID | K183194 |
| 510k Number | K183194 |
| Device Name: | Arthrex Eclipse Shoulder Prosthesis System |
| Classification | Total Shoulder Arthroplasty System |
| Applicant | Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | David L Rogers |
| Correspondent | David L Rogers Arthrex Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Product Code | QHQ |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-19 |
| Decision Date | 2019-07-26 |
| Summary: | summary |