K041858 is an FDA 510(k) clearance for the ACUMED ANATOMIC RADIAL HEAD SYSTEM. This device is classified as a Prosthesis, Elbow, Hemi-, Radial, Polymer (Class II - Special Controls, product code KWI).
Submitted by Acumed, LLC (Hillsboro, US). The FDA issued a Cleared decision on October 5, 2004, 88 days after receiving the submission on July 9, 2004.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3170.
| 510(k) Number | K041858 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2004 |
| Decision Date | October 05, 2004 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWI — Prosthesis, Elbow, Hemi-, Radial, Polymer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3170 |