Medical Device Manufacturer · US , Naples , FL

Catalyst Orthoscience, Inc.

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

Catalyst Orthoscience, Inc. — FDA 510(k) Submissions

Catalyst Orthoscience, Inc. has submitted 12 FDA 510(k) premarket notifications since 2018, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Shoulder Prosthesis, Reverse Configuration, Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented, Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Catalyst F1x Shoulder System
K252418 · KWS Prosthesis, Shoulder,... · Orthopedic
Nov 2025 97d
Catalyst F1x Shoulder System
K234105 · PHX Shoulder Prosthesis,... · Orthopedic
Apr 2024 101d
Catalyst R1 Reverse Shoulder System
K232583 · PHX Shoulder Prosthesis,... · Orthopedic
Sep 2023 26d
Catalyst R1 Reverse Shoulder System
K223655 · PHX Shoulder Prosthesis,... · Orthopedic
May 2023 154d
Catalyst EA Convertible Stemmed Shoulder
K222317 · KWS Prosthesis, Shoulder,... · Orthopedic
Nov 2022 100d
Catalyst R1 Reverse Shoulder System
K213349 · PHX Shoulder Prosthesis,... · Orthopedic
Jun 2022 258d
Catalyst R1 Reverse Shoulder System
K211991 · PHX Shoulder Prosthesis,... · Orthopedic
Jul 2021 30d
Catalyst OrthoScience R1 Reverse Shoulder System
K202611 · PHX Shoulder Prosthesis,... · Orthopedic
Feb 2021 156d
Catalyst OrthoScience CSR Shoulder System
K191811 · KWT Prosthesis, Shoulder,... · Orthopedic
Sep 2019 68d
Catalyst CSR Press-Fit Humeral Components
K182500 · KWT Prosthesis, Shoulder,... · Orthopedic
Jan 2019 121d
Catalyst CSR Shoulder System
K181287 · KWT Prosthesis, Shoulder,... · Orthopedic
Jul 2018 57d
Catalyst CSR 3 Peg Glenoids
K173812 · KWT Prosthesis, Shoulder,... · Orthopedic
Mar 2018 84d
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