Cleared Special

Catalyst OrthoScience CSR Shoulder System

K191811 · Catalyst Orthoscience, Inc. · Orthopedic

Sep 2019

Decision

68d

Days

Class 2

Risk

About This 510(k) Submission

K191811 is an FDA 510(k) clearance for the Catalyst OrthoScience CSR Shoulder System, a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II — Special Controls, product code KWT), submitted by Catalyst Orthoscience, Inc. (Naples, US). The FDA issued a Cleared decision on September 11, 2019, 68 days after receiving the submission on July 5, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K191811 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 05, 2019
Decision Date	September 11, 2019
Days to Decision	68 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3650