K781735 is an FDA 510(k) clearance for the ENDOPROSTHESIS SYSTEM, VARIO-HEAD. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by Waldemar Link GmbH & Co. KG (Mchenry, US). The FDA issued a Cleared decision on October 24, 1978, 12 days after receiving the submission on October 12, 1978.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K781735 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 12, 1978 |
| Decision Date | October 24, 1978 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWY — Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3390 |