Catalyst Orthoscience, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K252418 | Catalyst F1x Shoulder System | November 6, 2025 |
| K234105 | Catalyst F1x Shoulder System | April 5, 2024 |
| K232583 | Catalyst R1 Reverse Shoulder System | September 20, 2023 |
| K223655 | Catalyst R1 Reverse Shoulder System | May 9, 2023 |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | November 10, 2022 |
| K213349 | Catalyst R1 Reverse Shoulder System | June 23, 2022 |
| K211991 | Catalyst R1 Reverse Shoulder System | July 28, 2021 |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | February 12, 2021 |
| K191811 | Catalyst OrthoScience CSR Shoulder System | September 11, 2019 |
| K182500 | Catalyst CSR Press-Fit Humeral Components | January 11, 2019 |
| K181287 | Catalyst CSR Shoulder System | July 12, 2018 |
| K173812 | Catalyst CSR 3 Peg Glenoids | March 9, 2018 |
| K152825 | Catalyst CSR Shoulder System | May 11, 2016 |