K040432 is an FDA 510(k) clearance for the SOLAR 2 ANATOMIC SHOULDER. This device is classified as a Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented (Class II - Special Controls, product code HSD).
Submitted by Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on January 7, 2005, 323 days after receiving the submission on February 19, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3690.
| 510(k) Number | K040432 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2004 |
| Decision Date | January 07, 2005 |
| Days to Decision | 323 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 |