K151456 is an FDA 510(k) clearance for the Small Bone Nail Implant. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Vilex IN Tennessee, Inc. (Mcminnville, US). The FDA issued a Cleared decision on October 29, 2015, 150 days after receiving the submission on June 1, 2015.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K151456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2015 |
| Decision Date | October 29, 2015 |
| Days to Decision | 150 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 |