CATALYST ORTHOSCIENCE Inc
Naples, FL, US
CATALYST ORTHOSCIENCE Inc appears in FDA device records in Naples, FL. FDA records list 13 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 13 510(k) clearances for CATALYST ORTHOSCIENCE Inc between 2016 and 2025. The busiest year on record is 2018, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 2 |
| 2021 | 2 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252418 | Catalyst F1x Shoulder System | KWS | Substantially Equivalent | |
| K234105 | Catalyst F1x Shoulder System | PHX | Substantially Equivalent | |
| K232583 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | |
| K223655 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | |
| K222317 | Catalyst EA Convertible Stemmed Shoulder | KWS | Substantially Equivalent | |
| K213349 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | |
| K211991 | Catalyst R1 Reverse Shoulder System | PHX | Substantially Equivalent | |
| K202611 | Catalyst OrthoScience R1 Reverse Shoulder System | PHX | Substantially Equivalent | |
| K191811 | Catalyst OrthoScience CSR Shoulder System | KWT | Substantially Equivalent | |
| K182500 | Catalyst CSR Press-Fit Humeral Components | KWT | Substantially Equivalent | |
| K181287 | Catalyst CSR Shoulder System | KWT | Substantially Equivalent | |
| K173812 | Catalyst CSR 3 Peg Glenoids | KWT | Substantially Equivalent | |
| K152825 | Catalyst CSR Shoulder System | KWT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3012552981 | 3012552981 | CATALYST ORTHOSCIENCE Inc | 14710 Tamiami Trail N., Suite #102, Naples, FL 34110 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain