The following data is part of a premarket notification filed by Medshape, Inc. with the FDA for Dynanail Ttc Fusion System.
| Device ID | K171376 |
| 510k Number | K171376 |
| Device Name: | DynaNail TTC Fusion System |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, GA 30318 |
| Contact | Courtney Kline |
| Correspondent | Courtney Kline MedShape, Inc. 1575 Northside Drive, Suite 440 Atlanta, GA 30318 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-10 |
| Decision Date | 2017-11-02 |
| Summary: | summary |