K131845 is an FDA 510(k) clearance for the ACUMED ANATOMIC RADIAL HEAD SYSTEM, ACUMED ANATOMIC RADIAL HEAD LONG STEMS, ACUMED ARH SLIDE-LOC. 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 September 30, 2013, 101 days after receiving the submission on June 21, 2013.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3170.
| 510(k) Number | K131845 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 21, 2013 |
| Decision Date | September 30, 2013 |
| Days to Decision | 101 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 |