Medical Device Manufacturer · US , Naples , FL

Catalyst Orthoscience, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2018
12
Total
12
Cleared
0
Denied

Catalyst Orthoscience, Inc. has 12 FDA 510(k) cleared orthopedic devices. Based in Naples, US.

Latest FDA clearance: Nov 2025. Active since 2018.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Catalyst Orthoscience, Inc.
12 devices
1-12 of 12
Cleared Nov 06, 2025
Catalyst F1x Shoulder System
K252418 · KWS
Orthopedic · 97d
Cleared Apr 05, 2024
Catalyst F1x Shoulder System
K234105 · PHX
Orthopedic · 101d
Cleared Sep 20, 2023
Catalyst R1 Reverse Shoulder System
K232583 · PHX
Orthopedic · 26d
Cleared May 09, 2023
Catalyst R1 Reverse Shoulder System
K223655 · PHX
Orthopedic · 154d
Cleared Nov 10, 2022
Catalyst EA Convertible Stemmed Shoulder
K222317 · KWS
Orthopedic · 100d
Cleared Jun 23, 2022
Catalyst R1 Reverse Shoulder System
K213349 · PHX
Orthopedic · 258d
Cleared Jul 28, 2021
Catalyst R1 Reverse Shoulder System
K211991 · PHX
Orthopedic · 30d
Cleared Feb 12, 2021
Catalyst OrthoScience R1 Reverse Shoulder System
K202611 · PHX
Orthopedic · 156d
Cleared Sep 11, 2019
Catalyst OrthoScience CSR Shoulder System
K191811 · KWT
Orthopedic · 68d
Cleared Jan 11, 2019
Catalyst CSR Press-Fit Humeral Components
K182500 · KWT
Orthopedic · 121d
Cleared Jul 12, 2018
Catalyst CSR Shoulder System
K181287 · KWT
Orthopedic · 57d
Cleared Mar 09, 2018
Catalyst CSR 3 Peg Glenoids
K173812 · KWT
Orthopedic · 84d
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