K160264 is an FDA 510(k) clearance for the Additive Orthopaedics Hammertoe Correction System. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Additive Orthopaedics, LLC (Little Silver, US). The FDA issued a Cleared decision on June 1, 2016, 120 days after receiving the submission on February 2, 2016.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K160264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 2016 |
| Decision Date | June 01, 2016 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY - Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |