Copeland Eas Shoulder System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: COPELAND EAS SHOULDER SYSTEM FDA UDI
Generic Name: Resurfacing humeral head prosthesis FDA UDI
Model / Reference: 11-114662 FDA UDI

Identifiers

Catalog Number: 11-114662 FDA UDI
Primary DI / UDI-DI: 00880304439931 FDA UDI
510(k) Number: K051843 FDA UDI
FDA Product Code: HSD FDA UDI
KWS FDA UDI
KWT FDA UDI
MBF FDA UDI
GMDN Term: Resurfacing humeral head prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3690 FDA UDI
888.3660 FDA UDI
888.3650 FDA UDI
888.3670 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Resurfacing humeral head prosthesis

The COPELAND EAS SHOULDER SYSTEM is a cutting-edge, FDA-cleared device designed to treat damaged shoulder joints with a resurfacing humeral head prosthesis. Using a metallic humeral cap made from titanium (Ti), cobalt-chrome (Co-Cr), or stainless steel, this device replaces the natural joint while preserving the humerus. It's ideal for patients seeking a durable and effective solution.

Similar devices

Also classified as Resurfacing humeral head prosthesis.

AEQUALIS RESURFACING HEAD — TORNIER, INC. · Class II
Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc · Class II
SMR System — Limacorporate · Class II
Catalyst CSR Shoulder System — CATALYST ORTHOSCIENCE Inc · Class II
Equinoxe — Exactech, Inc. · Class II
Titan™ Reverse Shoulder System — Ascension Orthopedics, Inc. · Class II
Titan™ — Ascension Orthopedics, Inc. · Class II
Titan Reverse Shoulder System — Smith & Nephew, Inc. · Class II

Cleared under the same submission

K051843 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 9bdb966a-8c06-4be0-82f4-8be4eb72972d 36 fields · synced Jul 20, 2026