K792200 is an FDA 510(k) clearance for the TILLMAN HIP RESURFACING REPLACEMT PROS.. 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 December 5, 1979, 34 days after receiving the submission on November 1, 1979.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3400.
| 510(k) Number | K792200 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1979 |
| Decision Date | December 05, 1979 |
| Days to Decision | 34 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 |