Copeland EAS Humeral Resurfacing Heads
FDA 510(k)Class II (US FDA 510(k))
by Biomet, Inc.
Identifiers
- 510(k) Number
- K051843 FDA 510(k)
- FDA Product Code
- HSD FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3690 FDA 510(k)
- Regulation Number
- 888.3690 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Copeland EAS Humeral Resurfacing Heads are orthopedic implants designed for shoulder arthroplasty. They are used in humeral head resurfacing arthroplasty, primarily for treating gleno-humeral osteoarthritis.
These devices are supplied as implants for surgical use in clinical settings. They are authorized under FDA 510(k) clearance K051843 with product code HSD product code and were determined to be substantially equivalent to a predicate device. The device is intended for use in orthopedic procedures as indicated by the advisory committee classification.
Frequently asked questions
What is the Copeland EAS Humeral Resurfacing Head used for?
The Copeland EAS Humeral Resurfacing Head is an orthopedic implant designed for humeral head resurfacing arthroplasty, primarily indicated for treating gleno-humeral osteoarthritis in shoulder joint procedures.
How is the Copeland EAS Humeral Resurfacing Head supplied and intended for use?
The device is supplied as an implant for surgical use in clinical settings, intended for orthopedic procedures involving shoulder arthroplasty where resurfacing of the humeral head is required.
What regulatory pathway was used for the Copeland EAS Humeral Resurfacing Head?
The device received FDA 510(k) clearance under submission number K051843, with product code HSD, and was determined to be substantially equivalent to a predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: COPELAND EAS HUMERAL RESURFACING HEADS - Innolitics, Copeland Resurfacing Heads - Biomet | FDA Evidence Review, Copeland EAS Humeral Resurfacing Heads - Biomet | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051843 | Class II | Active |
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Manufacturer
- Manufacturer
- Biomet, Inc.
Sources (1)
- FDA 510(k) K051843 24 fields · synced Sep 21, 2026