The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Apex 3d Total Ankle Replacement System.
| Device ID | K210390 |
| 510k Number | K210390 |
| Device Name: | Apex 3D Total Ankle Replacement System |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 |
| Contact | Haylie Hertz |
| Correspondent | Haylie Hertz Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-09 |
| Decision Date | 2021-03-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889795124579 | K210390 | 000 |
| 00889795132321 | K210390 | 000 |
| 00889795133380 | K210390 | 000 |
| 00889795133397 | K210390 | 000 |
| 00889795133403 | K210390 | 000 |
| 00889795133410 | K210390 | 000 |
| 00889795133427 | K210390 | 000 |
| 00889795133434 | K210390 | 000 |
| 00889795124562 | K210390 | 000 |
| 00889795128577 | K210390 | 000 |