K884658 is an FDA 510(k) clearance for the ZIMMER BEADED THREADED ACETABULAR CUP. This device is classified as a Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented (Class II - Special Controls, product code KWY).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 30, 1988, 23 days after receiving the submission on November 7, 1988.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3390.
| 510(k) Number | K884658 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1988 |
| Decision Date | November 30, 1988 |
| Days to Decision | 23 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 |