Cleared Traditional

COPELAND MB RESURFACING HUMERAL HEADS

K010657 · Biomet Manufacturing, Inc. · Orthopedic
Sep 2001
Decision
192d
Days
Class 2
Risk

About This 510(k) Submission

K010657 is an FDA 510(k) clearance for the COPELAND MB RESURFACING HUMERAL HEADS, a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II — Special Controls, product code HSD), submitted by Biomet Manufacturing, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 14, 2001, 192 days after receiving the submission on March 6, 2001. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3690.

Submission Details

510(k) Number K010657 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 2001
Decision Date September 14, 2001
Days to Decision 192 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

Similar Devices — HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

All 70
Univers Revers CA Head and Adapter
K233260 · Arthrex, Inc. · Feb 2024
Univers Revers Humeral Cup Implant
K221232 · Arthrex, Inc. · May 2022
AGILON? XO Shoulder Replacement System
K191433 · Implantcast GmbH · Nov 2020
Biocore9 Humeral Resurfacing System
K193122 · Biocore9, LLC · May 2020
OVOMotion Shoulder Arthroplasty System
K173964 · Arthrosurface, Inc. · Apr 2018
Arthrex Univers Revers Shoulder Prosthesis System
K161782 · Arthrex, Inc. · Nov 2016