The following data is part of a premarket notification filed by Engage Uni, Llc with the FDA for Engage™ Partial Knee System.
| Device ID | K190439 |
| 501k Number | K190439 |
| Device Name: | Engage™ Partial Knee System |
| Classification | Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer |
| Applicant | Engage UNI, LLC 5931 Brick Court, Suite 130 Winter Park, FL 32792 |
| Contact | Nicholas Slater |
| Correspondent | Nicholas Slater Engage Surgical 3225 N. Colorado St Chandler, AZ 85225 |
| Product Code | NJD |
| CFR Regulation Number | 888.3535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Orthopedic |
| 501k Review Panel | Orthopedic |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-25 |
| Decision Date | 2019-11-21 |