The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc. with the FDA for Catalyst Ea Convertible Stemmed Shoulder.
| Device ID | K222317 |
| 510k Number | K222317 |
| Device Name: | Catalyst EA Convertible Stemmed Shoulder |
| Classification | Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Applicant | Catalyst OrthoScience, Inc. 14710 Tamiami Trail North Naples, FL 34110 |
| Contact | Dale Davison |
| Correspondent | Dale Davison Catalyst OrthoScience, Inc. 14710 Tamiami Trail North Naples, FL 34110 |
| Product Code | KWS |
| Subsequent Product Code | HSD |
| Subsequent Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-08-02 |
| Decision Date | 2022-11-10 |