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 With Porex (tinbn) Coating, Link Sled Knee System With Porex (tinbn) Coating.
| Device ID | K152431 |
| 510k Number | K152431 |
| Device Name: | LINK Endo-Model Knee System With PorEx (TiNbN) Coating, Link Sled Knee System With PorEx (TiNbN) Coating |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | WALDEMAR LINK GMBH & CO. KG BARKHAUSENWEG 10 Hamburg, DE 22339 |
| Contact | Helmut D. Link |
| Correspondent | Andre Von Malotki WALDEMAR LINK GMBH & CO. KG BARKHAUSENWEG 10 Hamburg, DE 22339 |
| Product Code | KRO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-26 |
| Decision Date | 2016-05-09 |
| Summary: | summary |