The following data is part of a premarket notification filed by Paragon 28, Inc. with the FDA for Maven Patient-specific Instrumentation.
| Device ID | K202019 |
| 510k Number | K202019 |
| Device Name: | Maven Patient-Specific Instrumentation |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Paragon 28, Inc. 14445 Grasslands Dr. Englewood, CO 80112 |
| Contact | Haylie Hertz |
| Correspondent | Haylie Hertz Musculoskeletal Clinical Regulatory Advisers, LLC 1050 K Street NW, Suite 1000 Washington, DC 20001 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-21 |
| Decision Date | 2021-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889795111593 | K202019 | 000 |
| 00889795110596 | K202019 | 000 |
| 00889795110589 | K202019 | 000 |
| 00889795110572 | K202019 | 000 |
| 00889795110565 | K202019 | 000 |
| 00889795110558 | K202019 | 000 |
| 00889795110541 | K202019 | 000 |
| 00889795110534 | K202019 | 000 |
| 00889795110527 | K202019 | 000 |
| 00889795110510 | K202019 | 000 |
| 00889795110503 | K202019 | 000 |
| 00889795110497 | K202019 | 000 |
| 00889795110602 | K202019 | 000 |
| 00889795110619 | K202019 | 000 |
| 00889795110626 | K202019 | 000 |
| 00889795111548 | K202019 | 000 |
| 00889795111531 | K202019 | 000 |
| 00889795111524 | K202019 | 000 |
| 00889795111517 | K202019 | 000 |
| 00889795110695 | K202019 | 000 |
| 00889795110688 | K202019 | 000 |
| 00889795110671 | K202019 | 000 |
| 00889795110664 | K202019 | 000 |
| 00889795110657 | K202019 | 000 |
| 00889795110640 | K202019 | 000 |
| 00889795110633 | K202019 | 000 |
| 00889795110480 | K202019 | 000 |