Cleared Traditional

Biocore9 Humeral Resurfacing System

K193122 · Biocore9, LLC · Orthopedic
May 2020
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K193122 is an FDA 510(k) clearance for the Biocore9 Humeral Resurfacing System, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Biocore9, LLC (Whippany, US). The FDA issued a Cleared decision on May 15, 2020, 185 days after receiving the submission on November 12, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K193122 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2019
Decision Date May 15, 2020
Days to Decision 185 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3690

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