K042321 is an FDA 510(k) clearance for the MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD. This device is classified as a Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWT).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on January 28, 2005, 155 days after receiving the submission on August 26, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3650.
| 510(k) Number | K042321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 26, 2004 |
| Decision Date | January 28, 2005 |
| Days to Decision | 155 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWT — Prosthesis, Shoulder, Non-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3650 |