The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc. with the FDA for Catalyst Csr Shoulder System.
| Device ID | K181287 |
| 510k Number | K181287 |
| Device Name: | Catalyst CSR Shoulder System |
| Classification | Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| 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 | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-16 |
| Decision Date | 2018-07-12 |
| Summary: | summary |