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 |