K140390 is an FDA 510(k) clearance for the TITANIUM VERSA-DIAL HUMERAL HEAD PROSTHESIS. This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented (Class II - Special Controls, product code MBF).
Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on September 10, 2014, 208 days after receiving the submission on February 14, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3670.
| 510(k) Number | K140390 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 14, 2014 |
| Decision Date | September 10, 2014 |
| Days to Decision | 208 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBF — Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3670 |