K111352 is an FDA 510(k) clearance for the TALON DISTALFIX PROXIMAL 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 August 22, 2011, 101 days after receiving the submission on May 13, 2011.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K111352 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2011 |
| Decision Date | August 22, 2011 |
| Days to Decision | 101 days |
| Submission Type | Abbreviated |
| 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 |