K843950 is an FDA 510(k) clearance for the LINK CEMENTLESS SCREW-IN ACETABULAR CUP. This device is classified as a Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (Class III - Premarket Approval, product code KWA).
Submitted by Waldemar Link GmbH & Co. KG (E. Hanover, US). The FDA issued a Cleared decision on June 3, 1985, 237 days after receiving the submission on October 9, 1984.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3330.
| 510(k) Number | K843950 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1984 |
| Decision Date | June 03, 1985 |
| Days to Decision | 237 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | — |
| Product Code | KWA — Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) |
| Device Class | Class III - Premarket Approval |
| CFR Regulation | 21 CFR 888.3330 |