K032264 is an FDA 510(k) clearance for the MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Howmedica Osteonics Corp. (Allendale, US). The FDA issued a Cleared decision on August 8, 2003, 16 days after receiving the submission on July 23, 2003.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K032264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 23, 2003 |
| Decision Date | August 08, 2003 |
| Days to Decision | 16 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 |