Dynanail Mini Hybrid
Screw, Fixation, Bone
MedShape Inc
The following data is part of a premarket notification filed by Medshape Inc with the FDA for Dynanail Mini Hybrid.
Pre-market Notification Details
| Device ID | K203381 |
| 510k Number | K203381 |
| Device Name: | Dynanail Mini Hybrid |
| 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 | 2020-11-17 |
| Decision Date | 2021-01-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M97026010071300 | K203381 | 000 |
| M97026010071200 | K203381 | 000 |
| M97026010071100 | K203381 | 000 |
| M97026010071000 | K203381 | 000 |
| M97026010070900 | K203381 | 000 |
| M97026010070800 | K203381 | 000 |
| M97026010070700 | K203381 | 000 |
| M97026010070600 | K203381 | 000 |
| M97026010071400 | K203381 | 000 |
Trademark Results [Dynanail Mini Hybrid]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DYNANAIL MINI HYBRID 88891681 not registered Live/Pending |
MedShape, Inc. 2020-04-28 |
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