Cleared Traditional

Catalyst CSR 3 Peg Glenoids

K173812 · Catalyst Orthoscience, Inc. · Orthopedic

Mar 2018

Decision

84d

Days

Class 2

Risk

About This 510(k) Submission

K173812 is an FDA 510(k) clearance for the Catalyst CSR 3 Peg Glenoids, 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 March 9, 2018, 84 days after receiving the submission on December 15, 2017. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3650.

Submission Details

510(k) Number	K173812 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2017
Decision Date	March 09, 2018
Days to Decision	84 days
Submission Type	Traditional
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