K080590 is an FDA 510(k) clearance for the AOS 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 May 6, 2008, 64 days after receiving the submission on March 3, 2008.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K080590 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 03, 2008 |
| Decision Date | May 06, 2008 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| 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 |