← Product Code [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD) · K003044

# COPELAND RESURFACING HEADS (K003044)

_Biomet, Inc. · HSD · Dec 13, 2000 · Orthopedic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K003044

## Device Facts

- **Applicant:** Biomet, Inc.
- **Product Code:** [HSD](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD.md)
- **Decision Date:** Dec 13, 2000
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 888.3690
- **Device Class:** Class 2
- **Review Panel:** Orthopedic

## Regulatory Identification

A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K003044](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HSD/K003044)

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