The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc. with the FDA for Catalyst Orthoscience Csr Shoulder System.
| Device ID | K191811 |
| 510k Number | K191811 |
| Device Name: | Catalyst OrthoScience 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 | 2019-07-05 |
| Decision Date | 2019-09-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811596030162 | K191811 | 000 |
| 00811596030155 | K191811 | 000 |
| 00811596030148 | K191811 | 000 |
| 00811596030131 | K191811 | 000 |
| 00811596030124 | K191811 | 000 |
| 00811596030117 | K191811 | 000 |