K061019 is an FDA 510(k) clearance for the TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS. This device is classified as a Nail, Fixation, Bone (Class II - Special Controls, product code JDS).
Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on June 6, 2006, 54 days after receiving the submission on April 13, 2006.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K061019 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2006 |
| Decision Date | June 06, 2006 |
| Days to Decision | 54 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | JDS — Nail, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |