Company ยท US
Catalyst Orthoscience, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2025. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2025 | K252418 | Catalyst F1x Shoulder System Catalyst Orthoscience, Inc. | KWS |
| Apr 5, 2024 | K234105 | Catalyst F1x Shoulder System Catalyst Orthoscience, Inc. | PHX |
| Sep 20, 2023 | K232583 | Catalyst R1 Reverse Shoulder System Catalyst Orthoscience, Inc. | PHX |
| May 9, 2023 | K223655 | Catalyst R1 Reverse Shoulder System Catalyst Orthoscience, Inc. | PHX |
| Nov 10, 2022 | K222317 | Catalyst EA Convertible Stemmed Shoulder Catalyst Orthoscience, Inc. | KWS |
| Jun 23, 2022 | K213349 | Catalyst R1 Reverse Shoulder System Catalyst Orthoscience, Inc. | PHX |
| Jul 28, 2021 | K211991 | Catalyst R1 Reverse Shoulder System Catalyst Orthoscience, Inc. | PHX |
| Feb 12, 2021 | K202611 | Catalyst OrthoScience R1 Reverse Shoulder System Catalyst Orthoscience, Inc. | PHX |
| Sep 11, 2019 | K191811 | Catalyst OrthoScience CSR Shoulder System Catalyst Orthoscience, Inc. | KWT |
| Jan 11, 2019 | K182500 | Catalyst CSR Press-Fit Humeral Components Catalyst Orthoscience, Inc. | KWT |
| Jul 12, 2018 | K181287 | Catalyst CSR Shoulder System Catalyst Orthoscience, Inc. | KWT |
| Mar 9, 2018 | K173812 | Catalyst CSR 3 Peg Glenoids Catalyst Orthoscience, Inc. | KWT |
| May 11, 2016 | K152825 | Catalyst CSR Shoulder System Catalyst Orthoscience, LLC | KWT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||