The following data is part of a premarket notification filed by Catalyst Orthoscience, Inc with the FDA for Catalyst Csr 3 Peg Glenoids.
| Device ID | K173812 |
| 510k Number | K173812 |
| Device Name: | Catalyst CSR 3 Peg Glenoids |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-15 |
| Decision Date | 2018-03-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851388006890 | K173812 | 000 |
| 00851388006883 | K173812 | 000 |
| 00851388006876 | K173812 | 000 |
| 00851388006821 | K173812 | 000 |
| 00851388006814 | K173812 | 000 |
| 00851388006807 | K173812 | 000 |
| 00851388006791 | K173812 | 000 |
| 00851388006784 | K173812 | 000 |
| 00851388006777 | K173812 | 000 |