K180087 is an FDA 510(k) clearance for the A.M. Surgical Intramedullary Fixation Device. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by A.M. Surgical, Inc. (Smithtown, US). The FDA issued a Cleared decision on May 18, 2018, 126 days after receiving the submission on January 12, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K180087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2018 |
| Decision Date | May 18, 2018 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Statement |
| Product Code | HTY - Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |