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 |