The following data is part of a premarket notification filed by Medshape, Inc. with the FDA for Dynanail Mini.
| Device ID | K182677 |
| 510k Number | K182677 |
| Device Name: | DynaNail Mini |
| Classification | Screw, Fixation, Bone |
| Applicant | Medshape, Inc. 1575 Northside Drive, Suite 440 Atlanta, GA 30318 |
| Contact | Akhilesh Gokhale |
| Correspondent | Akhilesh Gokhale Medshape, Inc. 1575 Northside Drive, Suite 440 Atlanta, GA 30318 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-26 |
| Decision Date | 2019-02-14 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DYNANAIL MINI 88023398 not registered Live/Pending |
MedShape, Inc. 2018-07-02 |