The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc with the FDA for Catalyst R1 Reverse Shoulder System.
| Device ID | K213349 |
| 510k Number | K213349 |
| Device Name: | Catalyst R1 Reverse Shoulder System |
| Classification | Shoulder Prosthesis, Reverse Configuration |
| Applicant | Catalyst OrthoScience, Inc 14710 Tamiami Trail North, Suite 102 Naples, FL 34110 |
| Contact | Dale Davison |
| Correspondent | Dale Davison Catalyst OrthoScience, Inc 14710 Tamiami Trail North, Suite 102 Naples, FL 34110 |
| Product Code | PHX |
| CFR Regulation Number | 888.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-10-08 |
| Decision Date | 2022-06-23 |