K122541 is an FDA 510(k) clearance for the ORTHOFIX CONTOURS PROIMAL HUMERAL PLATE (PHP). This device is classified as a Appliance, Fixation, Nail/blade/plate Combination, Single Component (Class II - Special Controls, product code KTW).
Submitted by Orthofix Srl (West Linn, US). The FDA issued a Cleared decision on September 20, 2012, 30 days after receiving the submission on August 21, 2012.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K122541 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2012 |
| Decision Date | September 20, 2012 |
| Days to Decision | 30 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 |