The following data is part of a premarket notification filed by Stelkast, Inc. with the FDA for Genflex2 Total Knee System - Ultra-congruent Cr Tibial Insert.
| Device ID | K173875 |
| 510k Number | K173875 |
| Device Name: | GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | StelKast, Inc. 200 Hidden Valley Road Mcmurray, PA 15317 |
| Contact | Dave Stumpo |
| Correspondent | Hollace Rhodes Musculoskeletal Clinical Regulatory Advisors 1050 K Street NW Suite 1000 Washington, DC 20001 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-21 |
| Decision Date | 2018-01-19 |
| Summary: | summary |