K160409 is an FDA 510(k) clearance for the AOS Anterolateral Proximal Humeral Plate. This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Single Component (Class II - Special Controls, product code KTW).
Submitted by Advanced Orthopaedic Solutions, Inc. (Torrance, US). The FDA issued a Cleared decision on March 15, 2016, 28 days after receiving the submission on February 16, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K160409 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 2016 |
| Decision Date | March 15, 2016 |
| Days to Decision | 28 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KTW - Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |