Copeland MB Resurfacing Humeral Heads

Q: What is the product code of K010657?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.

FDA 510(k) K010657 · Biomet Manufacturing, Inc.

Substantially Equivalent

510(k) numberK010657

Submission

Device name: Copeland MB Resurfacing Humeral Heads
Applicant: Biomet Manufacturing, Inc.
Warsaw, IN, US
Received: March 6, 2001
Decision date: September 14, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Device class: Class II (moderate risk)
Regulation: 21 CFR 888.3690
Specialty: Orthopedic
Implant: Yes

Other 510(k)s with product code HSD

510(k)	Device	Applicant	Decision
K233260	Univers Revers CA Head and AdapterHSD · Traditional	Arthrex, Inc.	02/12/2024SE
K221232	Univers Revers Humeral Cup ImplantHSD · Special	Arthrex, Inc.	05/19/2022SE
K191433	AGILON® XO Shoulder Replacement SystemHSD · Traditional	Implantcast GmbH	11/12/2020SE
K193122	Biocore9 Humeral Resurfacing SystemHSD · Traditional	Biocore9, LLC	05/15/2020SE
K173964	OVOMotion Shoulder Arthroplasty SystemHSD · Traditional	Arthrosurface, Inc.	04/18/2018SE
K161782	Arthrex Univers Revers Shoulder Prosthesis SystemHSD · Traditional	Arthrex, Inc.	11/21/2016SE
K161620	Anatomical Shoulder Domelock Dome centricHSD · Traditional	Zimmer GmbH	11/01/2016SE
K151527	Arthrex Univers Revers CA Heads and AdaptersHSD · Traditional	Arthrex, Inc.	04/19/2016SE
K142942	HemiCAP Humeral Head XL (HHXL) Articular Resurfacing SystemHSD · Special	Arthrosurface, Inc.	12/19/2014SE
K131298	Exactech Equinoxe Resurfacing Humeral Head SystemHSD · Traditional	Exactech, Inc.	11/26/2013SE

More from Exactech, Inc.

510(k)	Device	Decision
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K211729	Comprehensive® Convertible Glenoid - Vivacit-E LinerPHX · Traditional	11/04/2021SE
K202232	Comprehensive Vault Reconstruction SystemPHX · Traditional	02/19/2021SE
K193038	Comprehensive Shoulder SystemMBF · Traditional	10/28/2020SE
K182516	Comprehensive Nano Stemless ShoulderPKC · Traditional	04/22/2019SE
K181611	Comprehensive Reverse Shoulder SystemPHX · Traditional	09/24/2018SE
K173411	Comprehensive Segmental Revision System (SRS)PHX · Traditional	02/08/2018SE
K172502	Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate…PHX · Traditional	01/03/2018SE
K163651	ExpressBraid Graft ManipulationGAT · Traditional	02/17/2017SE

Questions and answers

When was Copeland MB Resurfacing Humeral Heads cleared by the FDA?

Copeland MB Resurfacing Humeral Heads (K010657) received a 510(k) decision of Substantially Equivalent on September 14, 2001, 192 days after the submission was received.

What is the product code of K010657?

The FDA product code is HSD – Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented, a Class II (moderate risk) device regulated under 21 CFR 888.3690.