The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Dynamx Intramedullary Implant.
| Device ID | K170326 |
| 510k Number | K170326 |
| Device Name: | DynaMX Intramedullary Implant |
| Classification | Pin, Fixation, Smooth |
| Applicant | Arthrex, Inc. 1370 Creekside Boulevard Naples, FL 34108 -1945 |
| Contact | Howard L. Schrayer |
| Correspondent | Howard L. Schrayer MX Orthopedics, Corp. 1050 Waltham Street, Suite 510 Lexington, MA 02421 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-02 |
| Decision Date | 2017-07-20 |
| Summary: | summary |