K040128 is an FDA 510(k) clearance for the MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on March 26, 2004, 65 days after receiving the submission on January 21, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K040128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 21, 2004 |
| Decision Date | March 26, 2004 |
| Days to Decision | 65 days |
| Submission Type | Special |
| 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 |