K781490 is an FDA 510(k) clearance for the TILLMAN HIPSURFACE REPLACEMENT. This device is classified as a Prosthesis, Hip, Femoral, Resurfacing (Class II - Special Controls, product code KXA).
Submitted by Waldemar Link GmbH & Co. KG (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978, 23 days after receiving the submission on August 28, 1978.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3400.
| 510(k) Number | K781490 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 1978 |
| Decision Date | September 20, 1978 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KXA — Prosthesis, Hip, Femoral, Resurfacing |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3400 |