Cleared Traditional

Comprehensive Shoulder System

K193038 · Biomet Manufacturing Corp · Orthopedic

Oct 2020

Decision

363d

Days

Class 2

Risk

About This 510(k) Submission

K193038 is an FDA 510(k) clearance for the Comprehensive Shoulder System, a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II — Special Controls, product code MBF), submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on October 28, 2020, 363 days after receiving the submission on October 31, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3670.

Submission Details

510(k) Number	K193038 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2019
Decision Date	October 28, 2020
Days to Decision	363 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3670