The following data is part of a premarket notification filed by Waldemar Link Gmbh & Co. Kg with the FDA for Endoprosthesis System, Vario-head.
| Device ID | K781735 |
| 510k Number | K781735 |
| Device Name: | ENDOPROSTHESIS SYSTEM, VARIO-HEAD |
| Classification | Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Applicant | WALDEMAR LINK GMBH & CO. KG 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWY |
| CFR Regulation Number | 888.3390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-12 |
| Decision Date | 1978-10-24 |