The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Fracture Adapter Hemi Shoulder Prosthesis.
| Device ID | K181555 |
| 510k Number | K181555 |
| Device Name: | Arthrex Fracture Adapter Hemi Shoulder Prosthesis |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| 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 | KWS |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-13 |
| Decision Date | 2018-12-21 |
| Summary: | summary |