The following data is part of a premarket notification filed by Surgtech, Inc. with the FDA for Surgtech Genoll Total Knee System.
| Device ID | K191192 |
| 510k Number | K191192 |
| Device Name: | SurgTech GENOLL Total Knee System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | SurgTech, Inc. 24600 Center Ridge Road, Suite 195 Westlake, OH 44145 |
| Contact | Xuegong Yu |
| Correspondent | Kellen Hills Orchid Design 80 Shelton Technology Center Shelton, CT 06484 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-03 |
| Decision Date | 2019-08-01 |