The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Gemini Sl Total Knee System, Endo-model Knee System, And Sled Knee System With Link Porex (tinbn) Inhouse Coating.
| Device ID | K212742 |
| 510k Number | K212742 |
| Device Name: | GEMINI SL Total Knee System, Endo-Model Knee System, And Sled Knee System With LINK PorEx (TiNbN) Inhouse Coating |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Contact | Lydia Ditter |
| Correspondent | Terry Sheridan Powell LinkBio Corp. 69 King Street Dover, NJ 07801 |
| Product Code | JWH |
| Subsequent Product Code | HSX |
| Subsequent Product Code | KRO |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-30 |
| Decision Date | 2021-09-16 |