K152295 is an FDA 510(k) clearance for the Talon DistalFix Antegrade/Retrograde Femoral Nail. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Orthopedic Designs North America, Inc. (Tampa, US). The FDA issued a Cleared decision on November 3, 2015, 82 days after receiving the submission on August 13, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K152295 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2015 |
| Decision Date | November 03, 2015 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB - Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |