K051843 is an FDA 510(k) clearance for the COPELAND EAS HUMERAL RESURFACING HEADS. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 29, 2005, 84 days after receiving the submission on July 7, 2005.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K051843 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2005 |
| Decision Date | September 29, 2005 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSD — Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3690 |