K872985 is an FDA 510(k) clearance for the SAMUELSON 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 Protek, Inc. (Indianapolis, US). The FDA issued a Cleared decision on October 1, 1987, 62 days after receiving the submission on July 31, 1987.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3330.
| 510(k) Number | K872985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 1987 |
| Decision Date | October 01, 1987 |
| Days to Decision | 62 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 |