Cleared Traditional

StageOne? Shoulder Cement Spacer Molds

K221968 · Biomet, Inc. · Orthopedic
Sep 2022
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K221968 is an FDA 510(k) clearance for the StageOne? Shoulder Cement Spacer Molds, a Bone Cement, Antibiotic (Class II — Special Controls, product code MBB), submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 15, 2022, 72 days after receiving the submission on July 5, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.

Submission Details

510(k) Number K221968 FDA.gov
FDA Decision Cleared SESE
Date Received July 05, 2022
Decision Date September 15, 2022
Days to Decision 72 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code MBB — Bone Cement, Antibiotic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3027