The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Link Endo-model Knee System, Femoral Segments (augments), Uhmwpe.
| Device ID | K211768 |
| 510k Number | K211768 |
| Device Name: | LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Waldemar Link GmbH & Co. KG Oststraße 4-10 Norderstedt, DE 22844 |
| Contact | Stefanie Fuchs |
| Correspondent | Terry Sheridan Powell LinkBio Corp. 69 King Street Dover, NJ 07801 |
| Product Code | KRO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-08 |
| Decision Date | 2021-06-30 |