The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc. with the FDA for Catalyst Csr Press-fit Humeral Components.
| Device ID | K182500 |
| 510k Number | K182500 |
| Device Name: | Catalyst CSR Press-Fit Humeral Components |
| Classification | Prosthesis, Shoulder, Non-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 | KWT |
| CFR Regulation Number | 888.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-12 |
| Decision Date | 2019-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811596030087 | K182500 | 000 |
| 00811596030070 | K182500 | 000 |
| 00811596030063 | K182500 | 000 |
| 00811596030056 | K182500 | 000 |
| 00811596030049 | K182500 | 000 |
| 00811596030032 | K182500 | 000 |
| 00811596030025 | K182500 | 000 |
| 00811596030018 | K182500 | 000 |
| 00811596030001 | K182500 | 000 |