The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Phantom Small Bone Intramedullary Nail System.
| Device ID | K170693 |
| 510k Number | K170693 |
| Device Name: | Phantom Small Bone Intramedullary Nail System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Single Component |
| Applicant | Paragon 28, Inc. 4B Inverness Ct. E., STE 280 Englewood, CO 80112 |
| Contact | Frank S. Bono |
| Correspondent | Karen E. Warden BackRoads Consulting, Inc PO Box 566 Chesterland, OH 44026 -0566 |
| Product Code | KTW |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2017-06-19 |
| Summary: | summary |